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Trial Results for Longer-Lasting Covid Vaccines and More (Next Generation Update 17)

A vaccine vial is glaring fiercely at an aggressive coronavirus, thinking "Tick, tick, tick..." (Cartoon by Hilda Bastian.)

This month, there are clinical trial reports for 3 next generation Covid vaccines – including 2 self-amplifying mRNA vaccines that have shown early signs of being longer-lasting than current mRNA vaccines. The third is first full report of a clinical trial of a pancoronavirus vaccine – up to now, we have only seen a press release for trial results of another vaccine in this category.

In this update, I’ve also added 18 reports of preclinical studies, including another 2 showing intranasal vaccination reduced transmission among animals sharing the same air.

There is also news about developing versions of Covid for running the human challenge trials planned for mucosal vaccines. As usual, I have the news broken down into 3 categories of next-generation Covid vaccines (definitions below).

Mucosal vaccine news

There were no new clinical trials, or trial results, for mucosal vaccines this month. There was news on human challenge trial projects, plus several preclinical studies – including another 2 studies demonstrating reduced transmission among co-housed animals.

Human challenge trials news

There’s some news on where the MusiCC project is headed. That’s the international project, led by Imperial College London, that aims to test mucosal vaccines in human challenge trials – I wrote about it in March (Update 15). A group from Oxford University reported results of their attempt to develop a version of Covid that would be suitable for this kind of trial. Their phase 1 trial began in 2021, recruiting 36 participants by November 2022.

Despite escalating the dose, they weren’t able to infect any of the participants. Their vaccine was based on the original Covid, and by the time of their trial, people had either had Covid or been vaccinated. Imperial College’s successful trial had been earlier, when it was still possible to recruit a group of people in the UK who had not been infected, before vaccines rolled out.

In an interview discussing these new results, Christopher Chiu, the lead investigator for MusiCC, said that they are working on a version based on BA.5 Omicron: “Chiu says that his team is exploring the possibility of screening potential participants to identify those with low levels of immune protection against the BA.5 variant and any future challenge strains.”

New preclinical results:

I’ve added 7 preclinical reports on results for mucosal vaccines to my collection since the last update, including one mucosal vaccine in China that also aims to be variant-proof. Notable studies include:

  • National Cancer Institute (NIH NCI) (USA): This study in hamsters compared a booster of an intranasal protein subunit vaccine with an injection of Moderna’s mRNA vaccine. All the animals had a first injection of Moderna vaccine. A few weeks after their boosters, they were challenged with Covid infection, along with a comparison group of unvaccinated hamsters. Vaccinated hamsters were then individually housed with an unvaccinated one. The cages were sealed, and allowed no contact between the animals except for shared air. The vaccinated hamsters were similarly protected against getting sick with Covid, but those who had the intranasal booster had lower levels of virus in oral swabs. None of the animals the intranasally-boosted hamsters were housed with got infected, whereas 2 out of 3 of the animals housed with Moderna-boosted hamsters got infected. There has been one other preclinical report for this vaccine.
  • University of Guelph (Canada): This study in mice and hamsters tested one or 2 doses of an intranasal viral vector vaccine, based on Newcastle Disease Virus. It appears to be another vaccine based on the Castlevax/Icahn MtSinai vaccine. The vaccine is based on the original SARS-CoV-2, and animals were challenged with Delta and Omicron. The developers concluded that the vaccine provided protection for the 6 months of the study.
  • Israel Institute for Biological Research: This study reports on a mucosal version of BriLife, a VSV-based viral vector vaccine. The injection version is currently in clinical trials (records on this vax). Mice were vaccinated with 2 injections, 2 intranasal doses, or an injection followed by an intranasal dose, followed by a Covid challenge test. Hamsters were vaccinated with an injection followed by an intranasal dose. Those animals and unvaccinated hamsters had a Covid challenge test, and were then co-housed for 24 hours with unvaccinated, unchallenged hamsters, with shared air and limited contact, then tested for infection 3 days later. The developers reported that immunity was greater after intranasal boosters, and continued for the year of the study. Most of the co-housed unvaccinated hamsters showed signs of infection, while there was no detectable virus for the vaccinated hamsters and their co-housed animals.

Mucosal Covid vaccine overview

  • 5 mucosal vaccines are currently authorized for use, at least 1 in each of 6 countries. However, none have been authorized by a drug regulatory agency designated stringent, or listed, by WHO.
  • 28 mucosal vaccines have reached clinical trial, although at least one of those has been discontinued. These are tracked in a table below.
  • In addition to the 5 authorized mucosal vaccines, 4 have reached phase 2 trials, and another 2 have reached phase 2/3 trial.

US Project NextGen-funded trials in this category:

  • Project 2b (“mini-efficacy”) for the intranasal protein subunit vaccine from Castlevax (planned to start in the last quarter of 2024);
  • Project 2b for the intranasal live attenuated vaccine from Codagenix; and
  • Project 2b for the oral viral vector vaccine from Vaxart.

None of these trials has been registered at ClinicalTrials.gov as yet.

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Durable or “variant-proof” vaccine news

This month, there were clinical trial results for 2 vaccines in this category, both self-amplifying mRNA vaccines (SAM or samRNA) – including one that is already authorized in Japan. SAM doesn’t just leave a message and disappear, the way current mRNA vaccines do. It makes copies of itself inside our cells – similar to the way a virus works. Theoretically, leaving a blueprint behind enables longer-lasting immunity than mRNA can offer, and there is some evidence that it’s working out for some SAMs.

I also added new reports of preclinical research for 5 vaccines in this vaccine.

LUNAR-COV19 from Arcturus (USA) – combined results of a phase 1 to 3 trial

This vaccine was registered in Japan in November 2023, making it the only next generation Covid vaccine authorized by a drug regulator designated stringent or listed by the World Health Organization. The company has filed for authorization in Europe and is in discussion with the FDA in the US, and it has a partnership for manufacture with Australia’s CSL Seqirus.

I have an overview of this vaccine’s clinical trials here, including a summary of the first early results from the phase 3 trial in Vietnam. Later, the developers published 3- and 6-month data. By six months, neutralizing antibodies had fallen off substantially for the BNT-Pfizer vaccine, especially against Omicron strains. For LUNAR-COV19, there was substantially less waning, though there was some. (My summary here).

There is an updated version of the vaccine in trials, but the version in this trial is ARCT-154, the one that is authorized in Japan with the name LUNAR-COV19. The trial was an integrated phase 1 to 3 trial, and the new publication pools data from all 3 phases. The efficacy calculations come from the major phase 3 part of the trial, and are the same as for the preprint in my earlier summary. This is efficacy during a Delta wave:

  • Any confirmed Covid, including very mild disease with a single symptom: 56.6% (95% CI: 48.7–63.3).
  • Severe Covid: 95.3% (80.5–98.9), with 2 in the vaccine group and 41 in the placebo group.
  • Death from Covid: 86.5% (-7.4–98.3), with 1 death in the vaccine group and 9 in the placebo group.

The publication includes previously unpublished data from other parts of the trial, and safety data is pooled across all parts of the trial. Over 70% of participants had adverse systemic reactions after the first injection, most commonly fatigue. However, the rate of severe reactions was low, apparently less than 5% – I could only find a diagram, not the precise figures for this.

The authors report that the 12-month follow-up data from the phase 3 trial are being analyzed.

GRT-R918 from Gritstone Bio (USA) – more phase 1 trial results:

This is a self-amplifying mRNA vaccine. It is one of the vaccines funded by the US Government’s Project NextGen to run a mini-efficacy, phase 2b trial. The trial had been planned for early 2024, but the company has reported that it has been pushed back to later this year to allow for manufacturing improvements. The vaccine has also received funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Gates Foundation. If it makes it through to authorization, then some of this vaccine will be supplied to the international COVAX program.

The developers have been running 3 phase 1 trials: in the US, in the UK, and another in South Africa including people living with HIV. Last year, I summarized the previous trial data. It’s too early to know about this vaccine’s efficacy, but what we’ve seen so far included some signs of greater durability than first generation vaccines, and a high rate of short-lived adverse reactions (including chills, fever, and nausea).

The new data comes from the trial in South Africa. It began in 2022, and they released 2 posters of early results last year (in April and October). This new poster includes data for 12 months after vaccination for all trial participants, and adds Part D of the trial. There were 341 people altogether in the trial. In part D, there was an Omicron-adapted version of the vaccine (GRT-R918), in 50 adults up to 60 years of age, and 49 who were 60 or older. Some had been previously vaccinated and got only a booster, some had never had a Covid vaccine, and some are living with HIV.

Each of the 3 versions of the vaccine used in this trial resulted in increased immune responses to multiple Covid variants in most of the people vaccinated – and those signs of immunity were holding at 12 months.

(Records on this vax.)

Preclinical studies:

I added 6 reports of preclinical studies in this category this month:

  • PRIME-2-CoV (Germany): There were 2 publications for this ORFV-based viral vector vaccine developed at the University of Tübingen, with Speransa Therapeutics. One report was for the original Covid strain version, studied in mice, rats, and rabbits. The other was for a version adapted for the Beta variant, studied in mice and hamsters. That paper reports that a phase 1 clinical trial was successful. That trial has been terminated, noting “business reasons.” Presumably that is because of a decision to go ahead with a different version. The company’s website lists Delta and Omicron versions, with the Delta version apparently approaching a phase 1 trial.
  • Unnamed vax (Canada): This is a protein subunit vaccine, developed by the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan. The study in hamsters showed signs of immune response against 3 Covid variants.
  • Ad5-US (China): This is an adenovirus-based viral vector vaccine, developed by the Division of Arboviral Vaccines, NIFDC, Beijing. The study in mice compared injections and intranasal doses.
  • Unnamed vax (China): This is a rabies-based viral vector vaccine, developed at Jilin University in Changchun. The study was in mice.
  • Unnamed vax (Singapore, Australia): This is a dendritic cell vaccine, developed at the National University of Singapore and the Monash Biomedicine Discovery Institute. The study was in mice.

Durable or “variant-proof” vaccine overview

Note: This is a rather vague category, including vaccines that aim to be more durable. I’m not sure how many can be classified as aiming to be “variant-proof”.

Authorized vaccine:

There is one vaccine in this category that has been authorized by a drug regulatory authority designated by WHO has stringent, or listed – and tested against an mRNA vaccine:

  • LUNAR-COV19 (USA): This self-amplifying mRNA vaccine was authorized in Japan in November 2023.

US Project NextGen-funded trials in this category:

  • Phase 1 for TNX-1800 from Tonix (aiming for lifelong immunity);
  • Phase 2b (“mini-efficacy”) for Gritstone Bio (self-amplifying mRNA).

Neither of these trials has been registered at ClinicalTrials.gov as yet.

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Pancoronavirus vaccine news

Pancoronavirus vaccines aim to provide protection not only from variants of the SARS virus that causes Covid, but also against the next new coronavirus to spread among humans. This month, we got the first full publication of results from a clinical trial of a vaccine in this category, and a preclinical report from another.

Phase 1 results for the pancoronavirus vaccine from the US Walter Reed Army Institute of Research (WRAIR)

This vaccine is a protein subunit vaccine, based on the original Covid. Participants in this trial in the US were vaccinated back in 2021, and we now have a full report of results. As well as the safety and immunogenicity trial for the vaccine called SpFN/ALFQ, there was a study of what’s called a passive transfer for a challenge test in hamsters – a group were injected with immunoglobulin from vaccinated people’s blood.

There were 29 participants in this trial, who were randomly assigned to 2 injections of placebo, or a lower or higher dose of the vaccine. Of those, 9 left the study along the way, including 3 from the placebo group, and half of the 20 people who completed follow-up took up the option of a third injection. None of the people who withdrew from the study reportedly did so because of adverse reactions. The developers had intended to enrol more participants, but it became too difficult to recruit people who were unvaccinated and had not had Covid.

People in the trial showed signs of immune response to several Covid variants, including Delta and Omicron, as well as varying degrees of response for a range of other sarbecoviruses (the coronavirus subgroup that includes both Covid and the original SARS). Signs of immune response were stronger or coronaviruses more closely related to Covid, and there were no signs of immune response to MERS.

Almost everyone had systemic adverse reactions to the vaccine (88%), and 1 person had a severe fever that resolved within a few days (4%). The most common systemic reactions were fatigue and/or muscle aches.

In the passive transfer study, hamsters were injected with immunoglobulin (IgG) from trial participants who had 3 injections of the vaccine. Those hamsters were then given the original SARS, along with some injected with saline or a control IgG. Those injected with the trial participants’ immunoglobulin had lower rates of lung inflammation than the others.

There was no mention of proceeding to phase 2 with this particular version of the vaccine. WRAIR is now part of a collaboration involving the Sheba research institute in Israel, the NIH Vaccine Research Center, and Sanofi. There’s been no recent news on that.

Mosaic 8b (CalTech, USA and Oxford and Cambridge Universities) preclinical study report

This vaccine is based on proteins from 8 coronaviruses, and the developers have previously reported that the complexity of the vaccine would make it difficult to manufacture. In this latest study in mice, the developers reported that they had simplified the vaccine by fusing the proteins into 2 sets of 4, called a Quartet Nanocage design. The vaccine still resulted in signs of immune response to a range of sarbecoviruses, including Covid variants and the original SARS. This included testing for viruses other than the 8 on which the vaccine is based.

In a press release, the developers reported that a first-in-human clinical trial is planned to start early next year. Even with the simplified version, the vaccine remains complicated. No manufacturer was reported to be attached to the project.

The group also updated a preprint from earlier this year.

(Records on this vax.)

Pancoronavirus vaccine overview

A table below this post keeps track of vaccines I’ve added to this category so far that have publicly available preclinical results.

There are 5 of these vaccines in phase 1 clinical trials, with some results for 2 of them marked *:

  • DIOSynVax (Cambridge University spin-off, UK) – mRNA.
  • INSERM/LinkInVax (France) – protein subunit.
  • Osivax (France) – protein subunit.
  • * VBI Vaccines (Canada) – eVLP.
  • * Walter Reed Army Institute of Research (WRAIR, USA) – protein subunit.

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Addendum 1: List of authorized next generation Covid vaccines (with countries)

There are now 7 next-generation Covid vaccines authorized in 7 countries. Only one has been authorized by a drug regulatory agency designated stringent, or listed, by WHO – it’s in bold. I’ve listed the vaccines in 2 categories, in order of date of first authorization.

Mucosal:

  • Razi-Cov Pars (Iran), intranasal protein subunit vaccine: Iran (October 2021).
  • Sputnik (Russia), intranasal viral vector vaccine: Russia (April 2022).
  • Convidecia (China), inhaled viral vector vaccine: China (September 2022), Morocco (November 2022), Indonesia (March 2023).
  • iNCOVACC (USA/India), intranasal viral vector vaccine: India (September 2022).
  • Pneucolin (China), intranasal viral vector vaccine: China (December 2022).

Self-amplifying mRNA:

  • Gemcovac (India): India (June 2022).
  • LUNAR-COV19 (USA): Japan (November 2023).

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Addendum 2: Table of mucosal vaccines in clinical trials

No new entries since my previous update post.

Note: Where there is a link to “All records” for a vaccine, that’s in my public Zotero collection for the vaccine, and it may include non-mucosal studies for that vaccine. Notes on that collection are here. For details on how I track Covid vaccine progress to maintain that collection, see my background post.

Vaccine, type, manufacturerMucosal version(s)Phase 1 to 2 clinical trialsPhase 3+ trial(s)Phase 3+ efficacy or immunogenicity results
ACM-001
Protein subunit

ACM Biolabs (Singapore/Switzerland)
(All records)
Intranasal.Phase 1.
Results (press release only)
Ad5-nCoV (Convidecia Air)
Viral vector (adenovirus)

CanSino (China)
(All records)
Inhaled through the mouth using a nebulizer.Phase 1. Results.

Phase 1/2. Results (plus second later preprint).

Phase 1/2.
Results.

Phase 2 (aged 6-17 years).

Booster adapted for variant.
10,420 people in China (Phase 3).
Results.

1,350 people (Phase 3).

540 people, in Malaysia (Phase 3).

904 people in China (Phase 4).
Results.

360 people (Phase 4).

451 people (Phase 4). Results.
904 people: Comparison after 2-dose course of inactivated vax: Convidecia injection vs inhaled, protein subunit, or CoronaVac booster (Phase 4 results). Both injected & inhaled Convidecia had stronger impact on signs of immunity than the others; response after inhaled version was slower but longer-lasting than injected (which peaked then declined from day 14), better for Omicron though not as good for original virus. No measure of mucosal immunity used.

451 people: Comparison of different versions adapted for variant, including a bivalent version. Booster of inhaled Convidecia after previous vaccination with inactivated vaccine. Signs of immune response to Omicron were higher for the bivalent vaccine, though lower for the original SARS-CoV-2 strain.
Ad5-S
Viral vector (adenovirus)

State Key Laboratory for Infectious Disease/Guangzhou Enbao Biomedical Technology Co (China)
(All records)

Intranasal.Infection prevention study.
AdCOVID
Viral vector (adenovirus)

AltImmune (USA)
(All records)
Intranasal.Phase 1Results – press release only.

Discontinued after phase 1.
AdS+N
Viral vector (adenovirus)

ImmunityBio (USA)
(All records)

Intranasal, oral capsule, or sublingual.Phase 1 (oral).

Phase 1 (sublingual).
AeroVax (Ad5-triCoV)
Viral vector (adenovirus)

McMaster University/Canadian Institutes of Health Research (Canada)
(All records)
Aerosol.Phase 1 (& ChAd-triCoV/Mac).

Phase 2.
Avacc 10
Protein subunit

Intravacc (Netherlands)
(All records)
Intranasal.Phase 1.
Results (press release only)
bacTRL-Spike-1
Live attenuated

Symvivo (Canada)
(All records)
Oral.Phase 1.
BBV154 (iNCOVACC)
Viral vector (adenovirus)

Bharat Biotech (India)
(All records)

This vaccine is ChAd-SARS-CoV-2-S
Washington University in St Louis (USA)
(All records)

Intranasal.Phase 1.

Phase 2.

Small amount of data from these trials in the drug product information.

Phase 2/3.

Phase 2.
In India, 2-dose course of BBV154 vs 2-dose course of injected Covaxin inactivated vaccine (Phase 3 – and here).
Results (previously in preprint).

See also the drug product information.

875 people in India, booster trial (Phase 3).
2,971 previously unvaxed people were assigned for the intranasal iNCOVACC, 161 for injected Covaxin. This trial did not aim to assess disease outcomes. It took place during the first Omicron wave.

Signs of immune response were higher for iNCOVACC than Covaxin.

Adverse events rate very low (5% local and 3% systemic) – lower than for comparison group.
B/​HPIV3/​S-6P
Viral vector (parainfluenza)

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) (USA)
(All records)
Intranasal.Phase 1.
BV-AdCoV-1
Viral vector (adenovirus)

Wuhan BravoVax
(China)
(All records)
Inhaled through the mouth using a nebulizer.Phase 1.
ChAdOx1
Viral vector (adenovirus)

Oxford University (UK)
(This is the AstraZeneca vax)
(All records)
Intranasal.Phase 1.

Phase 1.

Results.
CoV2-OGEN1
Protein subunit

US Specialty Formulations/VaxForm (USA)
(All records)
Oral.Phase 1.
(Fully recruited, final dose in November 2022.)
Press release stating successful (without data) and progressing to phase 2 trial.
COVI-VAC
Live attenuated

Codagenix (USA, with the Serum Institute of India)
(All records)
Intranasal.
Phase 1.
Press release in 2021 stating successful (without data) and progressing to phase 2/3.
Preliminary results (conference abstract in 2021) and in a 2022 press release.
Results in 2023 (press release only).

Phase 1 (booster).
Phase 2/3, as part of the WHO Solidarity Trial for Vaccines in Mali. (Protocol.)
CVXGA1-001
Viral vector (parainfluenza)

CyanVac/Blue Lake Tech (USA)
(All records)
Intranasal.Phase 1.
Phase 2.
DNS1-RBD (Pneucolin)
Viral vector (influenza)

Beijing Wantai BioPharm (China)
(All records)
Intranasal.Phase 1.
Phase 2.
Joint results.
30,990 participants in Colombia, Philippines, South Africa, Vietnam.
Results (previously in preprint.)

5,400 participants in Ghana (Phase 3).
Comparison of 2 doses of intranasal vaccine 14 days apart, with placebo control, during circulation of Omicron. Included >13,000 previously unvaccinated people.

Efficacy shown 90 days after 2nd dose. There was some decline at 180 days.

Efficacy against symptomatic Covid:
No previous vax: 55.2% (CI 13.8 to 76.7)
Inactivated: 38.2% (CI -49.2 to 74.4)
Viral vector: 39.9% (CI -16.7 to 69.1)
mRNA: 10.1% (CI -45.9 to 44.5)

Efficacy against severe Covid:
No previous vax: 66.7% (CI 8.3 to 87.9)
Inactivated: 54.6% (CI -47.3 to 86.0)
Viral vector: 50.0% (CI -6.8 to 76.6)
mRNA: 19.5% (CI -39.2 to 53.4)

Efficacy against hospitalization:
100% (CI -9.2 to 100)

Adverse events were very low – similar to placebo. Less than 8% of people had a runny and/or blocked nose or sore throat.
GAM-COVID-VAC (rAd26-S – Sputnik Light)
Viral vector (adenovirus)

Gamaleya Research Institute (Russia)
Intranasal.Phase 1/2
7,000 participants in Russia (Phase 3 or phase 2/3 – not clear).
Mambisa
Protein subunit

Centre for Genetic Engineering & Biotechnology (CIGB) (Cuba)
(All records)
Intranasal drops.Phase 1/2.

Phase 1/2.
Results (report of a conference presentation).

Phase 2.
MV-014-212
Viral vector
(RSV)

Meissa Vaccines (USA)
(All records)
Intranasal drops or spray. Phase 1.
Results (press release).
This vaccine is in limbo because of the company’s financial difficulties.
MVA-SARS-2ST
Viral vector (MVA)

German Centre for Infection Research (DZIF)/IDT Biologika
(All records)
Inhalation.Phase 1.
CVAX-01
Viral vector (Newcastle Disease Virus)

Castlevax/Icahn Mt Sinai
(All records)
Intranasal.Phase 1.
Results (press release).
Patria (NDV-HXP-S/AVX-COVID-12-HEXAPRO)
Viral vector (Newcastle Disease Virus)

Laboratorio Avi-Mex (Mexico)
(All records on Patria, see also CVAX-01 for early development.)

Intranasal.Phase 1.
Results.

Phase 2.
Results.
Phase 2/3 for injected version only: Results.
PRAK-03202
Protein subunit

Oravax (USA) [Oravax was established by OraMed (Israel) to develop this vaccine, using Premas Biotech’s PRAK-03202 and their oral vaccine technology]
(All records on oral PRAK-03202, and on intramuscular version)
Oral.Phase 1 (in South Africa).
Results (press release only).
Razi-Cov Pars
Protein subunit

Razi Vaccine & Serum Research Institute (Iran)
(All records)
Intranasal (third dose after 2 injections).Phase 1.
Results.

Phase 2.
Results.

Phase 1 to 2 (in 12-17 year-olds).

Phase 4 (Booster).

Phase 1 to 2 (in 5-17 year-olds).
41,128 people in Iran, comparing the 3-dose course to 2-dose inactivated Sinopharm Beijing vax, only partially randomized (Phase 3).
Results
(Previous media report for the first 24,000 participants.)
The authors concluded Razi-Cov Pars was non-inferior to the inactivated vaccine, with similarly very low adverse events. However, the trial could not establish whether there was an advantage to an intranasal dose.
SC-Ad6-1
Viral vector (adenovirus)

Moat Bio/Tetherex (USA)
(All records)
Intranasal and inhaled.Phase 1.
Trial expanded to add an inhaled version (from 130 to 190 people). Results so far briefly mentioned in press release.
SpikoGen
Protein subunit

Vaxine (Australia)

(All records on mucosal and on all forms.)

Oral/sublingual.Phase 1.
(Unnamed)
Inactivated bacteria

DreamTec (Hong Kong)
(All records)
Oral.Phase 1.
Phase 1.
Phase 1.

Note: An article of preclinical results has been retracted over lack of ethics committee approval.
VXA-CoV2-1/VXA-CoV2-1.1-S
Viral vector
(adenovirus)

Vaxart (USA)
(All records)
Tablets.Phase 1.
Results.

Phase 2. (Recruiting: started October 1, 2021.)
Results (press release).
Omicron adaptation was developed for an Omicron challenge trial, originally planned for second half of 2023.

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Addendum 3: Pancoronavirus vaccines with preclinical results

* Indicates new entry since previous update post.

Developer
Country

Vaccine name
Type of:

Vaccine

Coronavirus
Preclinical resultsClinical trial status
Academia Sinica Taiwan
(Taiwan)

(Unnamed)
mRNA

All
Non-primate
Beijing University of Chemical Technology
(China)

(Unnamed)
Live attenuated pangolin coronavirus

All
Non-primate
California Institute of Technology (Caltech)
USA

Mosaic-8b
Protein subunit

Beta
Non-primate

Non-primate

Non-primate

Primate, non-primate

* Primate, non-primate (update) (previous version)

* Non-primate (new version of the vaccine)
Charité Universitätsmedizin Berlin
Germany

NILV-PanCoVac
Viral vector

All
Non-primate (mucosal)
China Cuba Joint Innovation Center
China, Cuba

Unnamed
Protein subunit

Sarbeco
Non-primate (mucosal)
Codiak
USA

exoVACC Pan Beta Coronavirus
Protein subunit

Beta
Article on development

Non-primate (conference slides)

Non-primate
(conference slides)
(This company began proceedings
in bankruptcy court. See news.)
DIOSynvax
UK

DIOS-CoVax/
pEVAC-PS
mRNA

Sarbeco
Non-primate

Non-primate
Phase 1 trial (incl. protocol)
(Up to 36 participants in the UK)
Began December 2021.
Fully recruited.
Expanded to another city – no trial register entry found.
Duke University
USA

RBD–scNP
Protein subunit

Beta
Primate

Primate

Primate, non-primate

Non-primate (previously in preprint)

Primate, non-primate
Francis Crick Institute
UK

(Unnamed)
Protein subunit with DNA boost

All
Non-primate
Fudan University
China

HR1LS
Protein subunit

Sarbeco
Primate, non-primate

Primate

Primate

Non-primate
Guangdong Pharmaceutical University
China

(Unnamed)
Protein subunit

All
Non-primate
INSERM Vaccine Research Institute/LinKinVax
France

PanCov (CD40.CoV2/RBDv)
Protein subunit
Sarbeco
Non-primate

Primate, non-primate

Primate

Non-primate (conference poster)
Phase 1/2 trial
(Up to 240 participants in France)
Booster trial, planned to start recruiting in February 2024.
Osivax
France

OVX033
Protein subunit

Sarbeco
Non-primatePhase 1 trial
(48 participants in France)
First participant vaccinated in February 2024.
Pennsylvania State University
USA

(Unnamed)
Protein subunit

All
Non-primate
Scripps Research Institute
USA

(Unnamed)
Protein subunit

Beta


Non-primate
SK Bioscience/ Uni of Washington/Uni of North Carolina at Chapel Hill
South Korea, USA

GBP511
Protein subunit

Sarbeco
Primate, non-primate (testing Covid vaccine GBP510 against other sarbecoviruses)
More on plans for adapting this vaccine – GBP510 authorized as SKYCovione. See the University of Washington research listed below in this table.
Stanford University
USA

DCFHP-alum
Protein subunit

Sarbeco
Primate
Erratum (correction to legend in a figure).

Non-primate
Sun Yat-Sen University
China

(Unnamed)
Protein subunit

Sarbeco
Non-primate
University of California Irvine/Techimmune
USA

(Unnamed)
Viral vector

Beta
Non-primate (previously in preprint)

Non-primate (mucosal) (previously in preprint)

Non-primate

(There was also a paper about this vaccine’s development in 2021.)
University of North Carolina at Chapel Hill
USA

(Unnamed)
Viral vector

Sarbeco
Non-primate
University of Toronto
Canada

(Unnamed)
Protein subunit

Sarbeco
Non-primate
University of Washington
USA

(Unnamed)
Protein subunit

Sarbeco
Non-primate
(Previously in preprint)

Non-primate

Non-primate (MERS vaccine developed on the same platform as GBP511.)
(See “GBP511” above in this table.)
University of Wisconsin-Madison (PanCorVac)
USA

(Unnamed)
Protein subunit

All
Non-primate

Non-primate

Non-primate

Non-primate
VBI Vaccines
Canada

VBI-2901
eVLP

All
Non-primate

Non-primate (Press release)
Phase 1 trial
(103 participants in Canada)
Began October 2022.
Fully recruited.
(Further background info.)
Results (press release only).
(101 participants)
Previously vaccinated people boosted with 2 low or high doses, or 1 high-dose. Limited data reported. Some signs of immune response to a range of coronaviruses, mostly lasting at least 5 months. No major safety concerns.
Walter Reed Army Institute of Research (WRAIR)
USA

SpFN/ALFQ
Protein subunit

Beta
Non-primate

Non-primate

Non-primate (incl RFN)

Non-primate

Primate

Primate

Primate (with J&J vax)
Phase 1 trial
(US)
Began April 2021, with 29 participants, including some on placebo.
Results.
Vaxed participants showed immune responses to several Covid variants and several sarbecoviruses, but no signs of response to MERS.
Walter Reed Army Institute of Research (WRAIR)
USA

RFN
Protein subunit

Beta
Non-primate (incl SpFN)

Primate
Yale University
USA

(Unnamed)
mRNA

All
Non-primate

Non-primate
Yale University/Xanadu Bio
USA

(Unnamed)
Protein subunit, intranasal booster

Sarbeco
Non-primate

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Addendum 4: Definitions of vaccine types

  • Mucosal vaccines: These enter the body the way the virus does – through mucosal tissues. It’s hoped that provides defence against infection. They can be administered via different routes – squirts or drops in the nose, inhaled through the mouth through a nebulizer (similar to an asthma medication), or in tablet, capsule, or sublingual form.
  • Pan-SARS-CoV-2 or “variant-proof” vaccines: These aim to provide protection against any variant of the coronavirus that causes Covid-19 – including future variants. I include vaccines that aim for greater durability in this group.
  • Pancoronavirus can be targeted to:
    • the “subgroup” the 2 SARS viruses came from (the sarbecovirus subgenus),
    • coronaviruses from the next level up (the genus, betacoronavirus, which includes lethal diseases like MERS, as well as common cold viruses), or
    • the whole coronavirus family – it has 4 genuses, including betacoronavirus and alphacoronavirus (with more common cold viruses).

I classify a vaccine as a pancoronavirus one when the developers are explicitly targeting coronaviruses more broadly than SARS-CoV-2, and have tested for signs of response to non-SARS-CoV-2 coronavirus(es) (or clearly plan to).

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You can keep up with my work at my newsletter, Living With Evidence. And I’m active on Mastodon: @hildabast@mastodon.online 

~~~~

For details on how I track Covid vaccine progress, see my background post. Notes on my collection of studies are here. The collection is in a public Zotero library you can dig into here.

Previous update posts on next generation Covid vaccines:

  1. Mucosal vaccines (March 2022)
  2. Pan-SARS-Cov-2 and pancoronavirus (July 2022)
  3. Mucosal vaccines (July 2022)
  4. Mucosal vaccines (September 2022)
  5. Mucosal vaccines (April 2023)
  6. Pancoronavirus vaccines (April 2023)
  7. Next generation (May 2023)
  8. Next generation (June 2023)
  9. Next generation (July 2023)
  10. Next generation (August 2023)
  11. Next generation (September 2023)
  12. Next generation (November 2023)
  13. Next generation (January 2024)
  14. Next generation (February 2024)
  15. Next generation (March 2024)
  16. Next generation (April 2024)


All my Absolutely Maybe Covid-19 vaccine posts

All previous Covid-19 posts at Absolutely Maybe

My posts at The Atlanticat WIRED, and debunking posts at my personal website.

Disclosures: My interest in Covid-19 vaccine trials is as a person worried about the virus, as my son is immunocompromised: I have no financial or professional interest in the vaccines. I have worked for an institute of the NIH in the past, but not the one working on vaccines (NIAID). More about me.

The cartoon is my own (CC BY-NC-ND license). (More cartoons at Statistically Funny.)

Discussion
  1. Where did you find that Arcturus was in talks with the FDA? I’ve been keeping an eye on this one and hadn’t seen anything on that. Do you think it may be available later this year in the US?

    1. I don’t think it’s possible for it be available in the US that soon. Their first priority appears to be Europe. The talks they mentioned with the FDA are an earlier stage of the process. It came from this press release: “A clinical research organization to conduct the trial has been engaged and the Company has received constructive feedback from several regulatory agencies, including the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), regarding the trial design.”

  2. Thanks so much for compiling this information!

    Mucosal vaccine seems very promising. From what I understood, you said that some mucosal vaccine are already approved and in use, in a few countries. Would you know if there is real world data that has been compiled on how well it ended up protecting the people who got it? Thank you!

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