More Trial Results and More Pancoronavirus Vaccines (NextGen Covid Vax Update 21)

In this update there’s some news on the upcoming big trial in the US City of Hope/National Cancer Institute Covid vaccine for people on cancer treatment. There’s news, too, on the rollout of a next generation Covid vaccine in Japan. And another call for vaccine developers interested in Project NextGen funding to go into clinical trial.

There are results for clinical trials of 3 mucosal vaccines from China and Cuba, including the 31st mucosal Covid vaccine to reach clinical trials. There are also 10 reports of preclinical studies of next generation Covid vaccines – including some new pancoronavirus (universal) vaccines from the Netherlands and UK. Since we’ve already had a couple of dangerous crossovers from coronaviruses in animals, having a vaccine to reach for if there’s another could make an important difference – even if it’s just a stopgap till a more effective targeted vaccine is ready.

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
• Durable or “variant-proof” vaccine news
• Pancoronavirus vaccine news
• Addendum 1: List of authorized vaccines (with countries)
• Addendum 2: Table of mucosal vaccines in clinical trials
• Addendum 3: Table of pancoronavirus vaccines with results
• Addendum 4: Definitions of vaccine types

Mucosal vaccine news

This update, there are clinical trial results for 3 mucosal vaccines from China and Cuba, as well as several reports of preclinical studies from the Spain, Thailand, and the USA – including one for an NIH-developed vaccine that is already in clinical trial. In addition, one of the vaccines from the UK in the pancoronavirus category below includes some intranasal administration in preclinical tests.

In other news, the US Government program, Project NextGen, is interested in funding proof-of-concept phase 1 trials for oral Covid vaccines. They have issued a call for developers to express interest in the next few weeks.

Clinical trials:

A phase 4 trial testing a booster of the original Convidecia (Ad5-nCoV from CanSino) during Omicron (China)

This viral vector vaccine is used in China and other countries, in injected or inhaled doses. This phase 4 trial included 4,089 participants who were randomized to either injected or inhaled vaccine booster in the middle of 2023. (Omicron began circulating in China in 2022.) In addition, 2,008 people who refused the booster but agreed to be followed up for Covid for 6 months were included as a control group. All participants were given Covid tests, and asked to test if they had symptoms, with weekly phone calls to remind them to test, and check if they had Covid. Anyone with a positive test had swabs to confirm Covid, and were then followed up.

There were 79 confirmed cases of Covid-19 from a week after vaccination: 22 of the 2,039 participants in the inhaled booster group, 23 of the 2,050 people in the injected booster group, and 34 in the control group. Everyone’s disease was mild. (In the 29 sequenced swabs, all were Omicron.)

Based on results from 14 days after the booster, the researchers concluded that the difference between the inhaled and injected doses was not statistically significant. However, the injection did not reach their effectiveness threshold, while the inhaled booster did, though it contained a lower dose of the vaccine:

• Effectiveness of the inhaled booster: 51.7% (95% CI 9.1 to 74.3);

• Effectiveness of the injected booster: 38.2% (95% CI -9.5 to 65.1).

The implication, they concluded, was that people who have hybrid immunity from previous vaccination and Covid-19 might benefit from additional mucosal immunity.

(All records on this vaccine in my collection here.)

A phase 1 to 2 trial of an intranasal booster of Mambisa vaccine (Cuba)

This is the first publication of clinical trial results for this protein subunit vaccine developed by the Centre for Genetic Engineering and Biotechnology (CIGB). It was a safety and immunogenicity trial for a single booster dose of Mambisa, or the injected Abdala vaccine, in 1,161 people who had previously had Covid. The Mambisa dose was delivered by an atomizer, nasal spray, or nose drops.

There were no serious adverse events reported for either vaccine. Around 10 to 12% of people having Mambisa via the different methods had adverse events, mostly a blocked or runny nose, and some headaches.

Both vaccines met the trial’s goals for immune responses, with 75% of the Mambisa group and 80% of the Abdala group showing increased immunity from the single dose.

(All records on this vaccine in my collection here.)

A phase 1 trial of an intranasal viral vector vaccine (China)

This vaccine, called NB2155, is based on Omicron with an adenovirus 5 vector. It was developed at Guangzhou Medical University and Guangzhou National Laboratory. This phase 1 trial included128 healthcare workers who had previously been vaccinated with inactivated vaccines. They received 2 doses of NB2155, by nasal spray, 28 days apart between November 30 and December 30, 2022. The researchers reported large increases in nasal signs of immune response, and some response in serum antibodies.

China’s zero Covid policies were lifted on December 7. Half the participants got Covid after the first dose, and no cases of Covid were reported between 3 and 90 days of the second dose.

(All records on this vaccine in my collection here.)

Preclinical studies:

Intranasal viral vector vaccine from the NIH’s National Institute of Allergy and Infectious Diseases (NIAD) (USA)

This vaccine has a parainfluenza vector, and it is already in clinical trial: A phase 1 trial was fully recruited in July this year. The developers’ new preclinical preprint reports on a pediatric version of the vaccine based on the original SARS-CoV-2, as well as adaptations for the Delta and Omicron (B.1.1.529) variants.

The vaccine was tested in hamsters. In challenge tests of those variants, the vaccine protected against virus replication in the lungs, with only low levels of virus detected in the upper respiratory system of some animals.

This is the fourth preclinical report for this vaccine, including one in primates. You can see all records for this vaccine in my collection here.

Other new preclinical reports:

• Inhaled viral vector vaccine (USA): This study in primates involved both the developers of ChAd-SARS-CoV-2-S at Washington University at St Louis, and a team from the Vaccine Research Center at the NIH’s NIAID. They compared the results of an injected Omicron-adapted Moderna vaccine and an Omicron-adapted version of the inhaled viral vector vaccine. The inhaled vaccine provided greater protection than the Moderna vaccine, including minimal virus replication in the upper airways. (All records on this vaccine in my collection here. A version of this vaccine was the basis for the Covaxin vaccine from Bharat Biotech in India.)

• Intranasal viral vector vaccine (Spain): This vaccine is based on modified virus Ankara (MVA), and was developed at the Centro Nacional de Biotecnología (CNB/CSIC). The new report tests an Omicron-adapted version (BA.1) in mice, compared with previous versions and a multivalent version, in both injected and intranasal doses. (All records on this vaccine in my collection here.)

• Intranasal virus-like particle vaccine (USA): This vaccine was developed at Yale University, and includes spike proteins from the original SARS-CoV-2 and Beta and Omicron variants. It was studied in mice, in injected and intranasal doses, with challenge tests of original virus, Delta, and Beta. A combination of injected and intranasal doses provided the most protection.

• Intranasal virus-like particle vaccine (Thailand): This vaccine was developed at Mahidol University. It was tested in injected and intranasal versions in mice, resulting in different types of immune response.

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.
• 31 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:

• Phase 1 for MPV/S-2P, the intranasal viral vector vaccine developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). This trial for 60 participants began recruiting in July 2024.

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

• Phase 2b for the intranasal viral vector vaccine from CyanVac (planned to start in 2024, in US fall).

Only the first of these trials (Phase 1) has been registered at ClinicalTrials.gov so far.

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Durable or “variant-proof” vaccine news

The self-amplifying mRNA vaccine from Arcturus Therapeutics is rolling out in October in Japan. It has been updated for the JN-1 strain. It is being distributed by Meiji Seika Pharma, with the trade name, Kostaive. Arcturus and CSL Seqirus are still planning on getting this vaccine into other countries, but no word on a timetable for that.

Some news, too, on the viral vector vaccine 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. The manufacturers, GeoVax, have reported that 80 sites in the US are confirmed for its Project NextGen-funded phase 2b (“mini-efficacy”) trial.

This update, I’ve added reports of preclinical studies for 2 vaccines in this category to my collection, from the USA and China.

An mRNA vaccine from University of Texas, Galveston (USA)

This group developed an mRNA vaccine that incorporates the spike protein of SARS-CoV-2, as well as an N-protein. In a study in hamsters, they tested mRNA-N vaccine alone, compared with the mRNA-S+N vaccine. The dual-protein vaccine was provided complete protection against the 2 immune-evasive types of Omicron in challenge tests (BA.5 and BQ.1).

The developers previously published another study in hamsters, testing for protection from the Delta and Omicron BA.1 variants.

A protein subunit vaccine from Anhui Medical University (China)

This group developed a bivalent Covid-19 vaccine, testing it against several variants in mice and hamsters. It’s the first report I’ve seen for this vaccine.

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, and an October rollout is planned, with the trade name, Kostaive.

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. This month, I have added 3 reports of preclinical studies for vaccines in this category, from the Netherlands and UK.

Virus-like particle vaccine from the University of Amsterdam (Netherlands)

This vaccine is multivalent, incorporating spike proteins from each of the 4 clades (sub-groups) of sarbecovirus. (The original SARS and SARS-CoV-2 come from different clades of sarbecovirus.) The 4 proteins were coupled to influenza virus membranes.

The vaccine was tested in mice. All the mice first got influenza vaccine, so that their immune systems would be experienced with influenza, and some groups were also exposed to proteins from SARS-CoV-2 and coronaviruses that cause common colds in humans.

For the vaccine tests, 4 groups were vaccinated each with a single one of the 4 proteins, another group with a mosaic of all 4, and another with a cocktail of the 4 individual vaccines. Another pair of groups were also infected first with SARS-CoV-2, to mimic humans’ widespread exposure to either Covid or Covid vaccine. One of those groups was vaccinated with the mosaic, and the other with the cocktail. The developers also tested vaccinated with 3-week and 6-week intervals between doses.

Blood was tested for signs of immune response (neutralizing antibodies) to a wide range of sarbecoviruses and other coronaviruses, including common cold viruses, both SARS (including Gamma and Delta Covid variants), and MERS.

The developers concluded that a pan-sarbecovirus vaccine is feasible. With the longer interval between doses, the multivalent vaccines resulted in immune responses to all the viruses.

Viral vector vaccine from Oxford University (UK)

The developers of the Oxford/AstraZeneca Covid vaccine have based a next generation vaccine on the same viral vector as their original vaccine (ChAd). Called ChAdOx1.COVconsv12, it is based on components in sarbecoviruses – the coronavirus subgenus that includes Covid and the original SARS.

The preclinical report includes tests in mice and hamsters, including some intranasal administration. Although this is intended to be a sarbecovirus vaccine, the hamsters were only challenged with SARS-CoV-2. The developers concluded that a small amount of their original Covid vaccine was needed along with the new one to provide enough protection.

mRNA and DNA vaccine from DIOSynVax (Cambridge University spin-off, UK)

These developers have a pancoronavirus vaccine in clinical trial. Their new preclinical study is a separate development, and it’s not clear to me if it’s part of the same developmental program. For now, I’m keeping the records tagged together.

In their new preclinical report, the developers tested mRNA and DNA vaccine they developed using genetic information from 2 Covid variants, in mice and guinea pigs. They compared it with vaccination based on the original version of SARS-CoV-2, heterologous boosting with a viral vector vaccine, and an Omicron version of an mRNA vaccine.

The developers reported that the experimental vaccines induced immune responses against all of the wide range of Covid variants they tested (including Beta, Gamma, Delta, and several types of Omicron).

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, manufacturer	Mucosal version(s)	Phase 1 to 2 clinical trials	Phase 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. 10,000 people in China (Phase 4). * Results for a 4,089 in the Ad5-nCoV arms.	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. *4,089 people, plus a 2,008 un-randomized unboosted control group: This trial tested the original vax during Omicron, with either an injected or inhaled booster. There wasn’t a significant difference between them, though the injected version fell below their ineffectiveness threshold and the inhaled one reached effectiveness despite having a smaller dose of vaccine.
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 1. Results – 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. Fully recruited by early July 2024.
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, Colombia, Kenya, Philippines, Sierra Leone. Fully recruited by July 2024. (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. 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.
* NB2155 Viral vector (Adenovirus 5) Guangzhou Medical University/ Guangzhou National Laboratory (All records)	Intranasal.	Phase 1.
CVAX-01 Viral vector (Newcastle Disease Virus) Castlevax/Icahn Mt Sinai (All records)	Intranasal.	Phase 1. Results (press release).
Ad5-S-Omicron BA.1 Viral vector (Adenovirus 5) Guangzhou Medical University/Guangzhou National Laboratory (China) (All records)	Intranasal	Phase 1. Results.
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. (Started October 1, 2021.) Results (press release). Additional brief results in presentation.

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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 results	Clinical trial status
Academia Sinica Taiwan (Taiwan) (Unnamed)	mRNA All	Non-primate
Baylor College of Medicine (USA) (Unnamed)	Protein subunit Beta	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) Primate and non-primate
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 * Non-primate (a different vaccine)	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
Georgia State University USA Om-S-MERS-RBD	Protein subunit All	Non-primate
Georgia State University USA (Unnamed)	Protein subunit Sarbeco	Non-primate Primate, non-primate Non-primate
Guangdong Pharmaceutical University China (Unnamed)	Protein subunit All	Non-primate
Korea Research Institute of Bioscience and Biotechnology South Korea (Unnamed)	Protein subunit Sarbeco	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-primate	Phase 1 trial (48 participants in France) First participant vaccinated in February 2024. Fully recruited in June 2024.
* Oxford University UK ChAdOx1.COVconsv12	Viral vector Sarbeco	Non-primate
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
State Key Laboratory of Respiratory Disease Guangzhou Medical University China (Unnamed)	Protein subunit Sarbeco	Primate and non-primate
Sun Yat-Sen University China (Unnamed)	Protein subunit Sarbeco	Non-primate
* University of Amsterdam Netherlands (Unnamed)	Virus-like particle 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 Houston/Auravax USA NanoSTING-NS	Protein subunit (intranasal) Sarbeco	Non-primate Non-primate Non-primate Primate, non-primate
University of North Carolina at Chapel Hill USA (Unnamed)	Viral vector Sarbeco	Non-primate (Previously in preprint)
University of North Carolina at Chapel Hill USA (Unnamed)	mRNA 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 

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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)

18. Next generation (June 2024)

19. Next generation (July 2024)

All my Absolutely Maybe Covid-19 vaccine posts

All previous Covid-19 posts at Absolutely Maybe

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

Disclosures: My interest in Covid-19 vaccine trials began as a person worried about the virus, as my son was 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.)