There’s a lot of big news in next generation Covid vaccine development this month, including clinical trial results for 2 vaccines. The…
More Signs of Broad Protection From Next Generation Covid Vaccines (Update 19)
This month, there are some clinical results for a mucosal next generation Covid vaccine – the 30th mucosal vaccine on my list of mucosal vaccines that have gone into clinical trial. Plus, I’ve added over a dozen preclinical reports to my collection, including more results showing prevention of transmission or durable immunity. And an intranasal vaccine based on an agent called a STING agonist showed strong protection from other coronaviruses, as well as protection against transmission.
The update starts with news from Project NextGen. After that, 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.
- News from US Project NextGen
- 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
News from US Project NextGen
As well as funding trials of next generation Covid vaccines, Project NextGen is funding research on the correlates of protection from authorized vaccines (studying levels of antibodies etc associated with effective vaccination). To try to ensure a group of participants that is more diverse than is usual for clinical trials based in hospitals and universities, they announced this month a pharmacy-based initiative to broaden access. About 20 Walgreens pharmacies in urban, suburban, and rural areas will be clinical trial sites, and “To recruit study volunteers, Walgreens will provide information on how and where to participate in the study.”
This decentralized trial will also get technical and other support from the Fred Hutch Cancer Center – and the Center has also been funded to support some of the next generation vaccine trials.
In other Project NextGen news, Castlevax – who will be running one of the phase 2b “mini-efficacy” trials for their intranasal vaccine – announced they received additional funding for that trial.
Finally, last update, I reported that a mucosal vaccine developed by the NIH’s NIAID was entering a phase 1 trial. Soon after, the NIH announced that recruitment had begun, and that this was the first Project NextGen-funded clinical trial.
Mucosal vaccine news
This month, I added a 30th mucosal vaccine that has gone into clinical trial. (I missed this one when it went into a clinical trial in China last year.) It’s an intranasal viral vector vaccine called Ad5-S-Omicron BA.1, based on adenovirus 5, and Omicron. The developers reported some results for 8 people in the phase 1 trial, along with a transmission study in mice.
The people in the clinical trial had been vaccinated with other vaccines at least 6 months before getting 2 doses of nasal spray. The developers tested their people’s blood and nasal fluids to see if they showed signs of immune response to new Omicron variants.
Nasal immunoglobulin, they reported, “retained potent neutralization” against all the Covid variants they tested, though serum immunoglobulins did not for all of them.
The developers then tested the impact on mice of intranasal application of the vaccinated people’s immunoglobulin. There were 4 groups of mice getting different immunoglobulin, and a control group getting immunoglobulin from people who did not have the intranasal vaccine. The mice getting the vaccinated people’s nasal immunoglobulin “showed a significant and comparable reduction in viral load.”
More new preclinical results:
I’ve added 7 preclinical reports on results for another 5 mucosal vaccines to my collection since the last update, with one reported below in the pancoronavirus vaccine category. The others include:
- Tokyo Metropolitan Institute of Medical Science and Toko Yakuhin Kogyo Co (Japan): This vaccine is a protein subunit mixed with carboxyvinyl polymer (CVP), tested intranasally in mice. The developers reported levels of longterm efficacy (at least 15 months).
- Friedrich Loeffler Institute (Germany) and University of Bern (Switzerland): This report is for genome-modified live-attenuated vaccines, tested as a single intranasal dose in mice and hamsters. For one of them, unimmunized hamsters put in contact with immunized animals after a Covid challenge test had minimal viral RNA in nasal washings and no signs of the virus in organs.
- Ohio State University (USA): This group developed several versions of viral vector vaccine based on 3 Covid variants. The viral vectors were measles and mumps components of the MMR vaccine. The developers reported on testing these intranasally in mice and hamsters.
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.
- 30 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.
Durable or “variant-proof” vaccine news
This was a slow month in this category, with preclinical results for just one vaccine. It is a pentavalent (5-variant) mRNA vaccine from Academia Sinica in Taiwan, tested in mice. These developers previously reported the results of a bivalent version of the 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.
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.
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, 3 vaccines have joined this category, all from the US.
NanoSTING-SN: A mucosal protein subunit vaccine from the University of Houston and Auravax (USA)
NanoSTING is the name for a mucosal adjuvant that is a STING agonist, a class of agents that can stimulate immune activity. (STING stands for stimulator of interferon genes.) Different versions of this vaccine were tested in mice and hamsters.
Hamsters got 2 intranasal doses of the SN version, and then had a challenge test with the Delta variant, along with an unvaccinated group. The vaccinated hamsters had reduced viral loads, and by day 6, no virus was detectable.
The developers did a transmission study using the SN version in hamsters. One group had sham immunization, and a group of 8 hamsters had 2 intranasal doses of SN, 21 days apart. The immunized hamsters were challenged with an Omicron variant on day 35, and a day later, each was co-housed with an unimmunized hamster.
The vaccine protected the 8 hamsters from getting sick, and only 2 showed a low amount of virus in lung and nasal tissue. No virus was detected in any of the contact hamsters. The experiment was repeated with a single intranasal dose: This also prevented transmission.
The developers tested blood from mice vaccinated with the SN version and found signs of immune response to a group of other coronaviruses, including the original SARS and MERS, as well as an alphacoronavirus.
Then, a group of vaccinated and unvaccinated mice were challenged with the original SARS. The unvaccinated mice showed signs of illness, but the vaccinated ones did not, and all survived.
Finally, the developers vaccinated 3 primates (rhesus macaques) with 2 intranasal doses, 28 days apart. Signs of immune response were consistent with those of the mice.
This is the fourth preclinical report for this vaccine – all records here.
A protein subunit vaccine from Georgia State University (USA)
Four versions of this vaccine were tested. One of them, based on the Delta variant, showed signs of protection from all the Covid variants tested. Immunized mice were also protected in challenge experiments with the Delta variant, and the original SARS.
This is the second preclinical report for this vaccine – the first is here.
A protein subunit vaccine from Baylor College of Medicine (USA)
This vaccine aims to provide protection from betacoronaviruses, and is based on components of the original SARS, MERS, and an Omicron variant. The vaccine was tested in mice. The mice showed signs of response to all of those viruses, as well as betacoronaviruses that are currently only infecting bats.
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.
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).
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. | 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 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 (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). | ||
* 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. (Recruiting: started October 1, 2021.) Results (press release). | Omicron adaptation was developed for an Omicron challenge trial, originally planned for second half of 2023. |
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) | |
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 | |
* Georgia State University (USA) (Unnamed) | Protein subunit Sarbeco | Primate, 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-primate | Phase 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 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 | |
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 |
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).
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:
- Mucosal vaccines (March 2022)
- Pan-SARS-Cov-2 and pancoronavirus (July 2022)
- Mucosal vaccines (July 2022)
- Mucosal vaccines (September 2022)
- Mucosal vaccines (April 2023)
- Pancoronavirus vaccines (April 2023)
- Next generation (May 2023)
- Next generation (June 2023)
- Next generation (July 2023)
- Next generation (August 2023)
- Next generation (September 2023)
- Next generation (November 2023)
- Next generation (January 2024)
- Next generation (February 2024)
- Next generation (March 2024)
- Next generation (April 2024)
17. Next generation (May 2024)
18. Next generation (June 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.)
Thank you for your detailed update!
Thanks for the updates. They keep the hope alive.
Will the Project Next-Gen phase 2b trials likely be the last before regulatory approval (given favourable outcomes of course)? … or will there then need to be phase 3 trials?
Thanks!
I don’t know. (The Codagenix vax is already in a phase 3 trial outside the US.)
Can you do a breakdown of Moderna’s 1238? I know that’s not technically under the Project NextGen umbrella but the results show an improvement over the standard Moderna shot and they’ve applied for approval.
I haven’t planned to, but I might take a look.