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A Mini-Surge of Clinical Trials and Advances for People with Immunosuppression (NextGen Covid Vax Update 18)

It's Superbooster! A cute blue-suited vaccine with red boots and a cape is flying with outstretched arm and fist. (Superman-inspired cartoon by Hilda Bastian.)

It’s been a slow month for reporting of results, but a big one for new trials and for potential improved vaccine boosters for people with immunosuppression.

There are 2 new trials registered – one for an intranasal vaccine from the US NIH’s NIAID, and one for an mRNA vaccine aiming to be more effective and more durable for people with immunosuppression or immunocompromise in Australia.

Plus, we heard that US Project NextGen is funding another couple of phase 2b “mini-efficacy” trials – one for another vaccine aiming to provide better protection to people with immunosuppression, and another intranasal vaccine. That brings the number of mucosal Covid vaccines reaching clinical trial to 29.

In other trial news, we also heard that one more phase 1 trial of a pancoronavirus vaccine has fully recruited. And in this update, I’ve also added 4 reports of preclinical studies, for 3 vaccines.

As usual, I have the news from the last month broken down into 3 categories of next-generation Covid vaccines (definitions below). Each of these sections ends with an overview of vaccines in the category.

Mucosal vaccine news

This month, the 29th mucosal vaccine for Covid headed into clinical trial, and US Project NextGen funded a phase 2b “mini-efficacy” trial for another intranasal vaccine. That brings the total they have funded in this category to 4. All but one have reported they plan to get started in 2024, with one recently saying if they start soon, then interim results could theoretically be available early in 2025. In each of these trials, the vaccine will go head-to-head with mRNA vaccine in 10,000 participants.

Another mucosal vaccine goes into clinical trial in the US

This vaccine is being developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). A viral vector vaccine, it’s based on murine pneumonia virus. The developers have published 2 preclinical studies for this vaccine, both in primates. The first study tested a single dose in macaques. In the second report, they tested 2 doses, and found that 3 out of 4 macaques did not get infected in a SARS-CoV-2 challenge, while all the control animals did.

The phase 1 trial is testing intranasal administration, in 3 different strengths. They planned to start recruiting 60 people this month, in Georgia, New York, and Texas.

Another mucosal vaccine gets ProjectNext Gen funding for a 2b “mini-efficacy” trial

This vaccine is an intranasal viral vector vaccine based on PIV5 (parainfluenza 5), developed by the University of Georgia with CyanVac. The vaccine has been in a phase 2 trial with 227 participants in the US. The developers provided some information about their phase 1 trial in a press release early this year.

They plan to start the Project NextGen-funded phase 2b trial in US fall.

New preclinical results:

I’ve added 2 preclinical reports on results for mucosal vaccines to my collection since the last update:

  • Wuhan Institute of Virology and Shenzhen Instititute of Advanced Technology (China): This is an intranasal protein subunit vaccine, tested in mice. It aims to be variant-proof.
  • Division of Respiratory Virus Vaccines, National Institutes for Food and Drug Control, Beijing (China): This is an intranasal protein subunit vaccine, tested intranasally and intraperitoneally in mice.

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.
  • 29 mucosal vaccines have reached clinical trial, although some of the vaccines are no longer in development. The vaccines that have entered clinical trials 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;
  • Project 2b for the oral viral vector vaccine from Vaxart (planned to start in 2024, possibly in US summer); and
  • Project 2b for the intranasal viral vector vaccine from CyanVac (planned to start in 2024, in US fall).

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’s news for 2 vaccines aiming to provide boosters that are more effective and more “variant-proof” for people with immunosuppression.

GEO-CM04S1 from GeoVax (USA):

This is a viral vector vaccine, based on modified Ankara virus (MVA). It was developed at the City of Hope with the NIH’s National Cancer Institute (NCI), to better serve immunocompromised people on cancer treatment.

Results released so far for this vaccine have been encouraging. For example, the developers previously published data for 13 participants with blood cancer, a subgroup of participants in a phase 2 trial. My previous summary on this: Their immune responses were similar or superior to those of healthy people receiving the vaccine and healthcare workers vaccinated with the BNT/Pfizer vaccine. And people were still showing signs of immunity after 6 months.

This month, GeoVax announced that they have received funding from Project NextGen to run a 10,000-participant phase 2b “mini-efficacy” trial. No word yet on timing for this.

This vaccine already has 3 ongoing phase 2 trials. In a recent company overview, a slide about GEO-CM04S1 mentioned that it was durable against variants for more than 12 months, but the data on this haven’t been published as far as I know. (Records in my collection for this vaccine here.)

HN-0001 from HelixNano (USA, Australia):

This is an mRNA vaccine, and a phase 1 safety trial of a booster dose in 48 healthy people has been registered in Australia; a group of people in this trial were registered separately. It includes a comparison group of people being vaccinated with the BNT/Pfizer vaccine.

I’ve included this vaccine in this category because early in the pandemic, a company spokesperson said they were trying to develop a “mutation-resistant” vaccine. This year, when they got the green light for a phase 1 trial, a company spokesperson described the vaccine as “a second-generation COVID-19 mRNA vaccine candidate specifically designed to prevent COVID-19 in immunosuppressed and immunocompromised populations.”

Other news:

There’s a bit of news for the vaccine from Tonix (USA), a company funded by Project NextGen to run a phase 1 trial. The developers gave a poster presentation this month. I don’t think the data on their Covid vax is new, but I didn’t scour through to be sure. However, the poster reiterates their plan to go into clinical trial this year. (The poster could be worth looking at if you’re interested in a technical overview of the platform, and why this pox-based vaccine platform is aiming for lifelong immunity from a single dose.)

Finally, the only preclinical report I added for this category of vaccine is the one for a mucosal vaccine already mentioned above (from the Wuhan and Shenzhen Institutes).

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) (planned to go into clinical trial in 2024);
  • Phase 2b (“mini-efficacy”) for Gritstone Bio (self-amplifying mRNA).
  • Phase 2b (“mini-efficacy”) for GeoVax (viral vector vaccine).

These trials have not 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.

Clinical trial news:

There are 4 of these vaccines in phase 1 clinical trials, and one in a phase 1/2 trial. This month, the developers announced that the phase 1 trial of the protein subunit vaccine from Osivax in France has fully recruited, with 48 participants. They had begun recruiting for the trial in February, and expect to get first results this year. This vaccine aims to provide protection to the subgroup of coronaviruses that include the ones causing Covid and the original SARS.

New preclinical results:

This month, I added 2 preclinical reports for a vaccine that’s new to my collection – one report from this month, and one I had missed in 2022.

The vaccine, called SARS2-S, is being developed in the US by researchers at Georgia State University and the University of Iowa. The developers have been testing 2 versions of their mRNA vaccine, and this new report shows how they settled on which to keep working on. This version of the vaccine includes a component of the virus that causes the Covid Omicron variant, with a part of it replaced with the equivalent component of the original SARS.

In the first part of the study, vaccinated and control mice were challenged with the Omicron variant of the virus, and the original SARS. Omicron isn’t life-threatening to these mice, so the developers measured signs of infection for the Omicron challenge test. Signs of immune response were high for the vaccinated mice. All the mice injected with the SARS-containing version of the vaccine survived the SARS challenge, and didn’t lose weight – whereas 40% of the control mice died, and weight loss was high among survivors.

Then, another group of mice were injected with serum from either vaccinated or control mice, and challenged with the original SARS virus. Signs of immune response were high for mice vaccinated with the SARS-containing-version.

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 (phase 1 trial fully recruited in June 2024).
  • * 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

* Indicates new entry since 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. Results (press release only).
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.
* MPV/S-2P
Viral vector (murine pneumonia)

National Institute of Allergy and Infectious Diseases (NIAID)
(USA)

(All records)
Intranasal drops.Phase 1.
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
* Georgia State University, University of Iowa
USA

SARS2-S (SARS-RBD)
mRNA

Sarbeco
Non-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.
* Fully recruited in June 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)

17. Next generation (May 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. I just want to thank you for doing this. My family is very concerned about long COVID and aren’t going back to “normal” until there is a vaccine that does better at preventing covid.

    Your articles keep me informed and give me hope. Thank you.

  2. Thank you so much for these comprehensive updates, they give us so much cautious hope.

    For the NIH phase I clinical trial, if all went well, would it be many more years until something like that became available in the US? Or could it be as early as next year?

    It looks like other mucosal vaccines are in 2 or 2b already, so maybe we’ll hear from those sooner, but I was trying to figure out how long each phase of clinical trial takes (again, assuming it is safe and effective).

    Thank you again for your time!

    1. It’s too hard to say, till we know who is manufacturing it, in what quantities, and whether they have applied to the FDA. I wrote a generic answer to this here.

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