NCT04441047: ALLOPRIME

Universal Anti-Viral Vaccine for Healthy Elderly Adults

Completed Phase 1, PHASE2 Last updated 14 January 2025

What this trial tests

Phase 1, PHASE2 trial testing AlloStim in Virus Diseases in 40 participants. Completed in 1 November 2024.

Timeline

12 July 2021

Primary endpoint
1 March 2023

1 November 2024

Quick facts

Lead sponsor	Mirror Biologics, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	12 July 2021
Primary completion	1 March 2023
Estimated completion	1 November 2024
Sites	4 locations across United States

Drugs / interventions tested

• AlloStim — full drug profile →

Conditions studied

• Virus Diseases — all drugs for Virus Diseases →
• Pneumonia — all drugs for Pneumonia →
• COVID-19 Respiratory Infection — all drugs for COVID-19 Respiratory Infection →
• RSV Pneumonia — all drugs for RSV Pneumonia →

Sponsor

Mirror Biologics, Inc. — full company profile →

Who can join

65 and older, any sex, with Virus Diseases or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of COVID-19 on the social, economic, environmental and energy domains: Lessons learnt from a global pandemic.
   Mofijur M, Fattah IMR, Alam MA, Islam ABMS, et al · · 2021 · cited 214× · PMID 33072833 · DOI 10.1016/j.spc.2020.10.016
2. The 2020 race towards SARS-CoV-2 specific vaccines.
   Karpiński TM, Ożarowski M, Seremak-Mrozikiewicz A, Wolski H, et al · · 2021 · cited 65× · PMID 33408775 · DOI 10.7150/thno.53691
3. COVID-19 in the elderly people and advances in vaccination approaches.
   Dhama K, Patel SK, Natesan S, Vora KS, et al · · 2020 · cited 33× · PMID 33270497 · DOI 10.1080/21645515.2020.1842683
4. An outlook on antigen-specific adoptive immunotherapy for viral infections with a focus on COVID-19.
   Monzavi SM, Naderi M, Ahmadbeigi N, Kajbafzadeh AM, et al · · 2021 · cited 9× · PMID 34217004 · DOI 10.1016/j.cellimm.2021.104398
5. SARS-CoV-2 vaccine development and how Brazil is contributing.
   Kanno AI, Barbosa MMF, Moraes L, Leite LCC. · · 2021 · cited 7× · PMID 33818582 · DOI 10.1590/1678-4685-gmb-2020-0320
6. Update on Influenza Vaccines: Needs and Progress.
   Kennedy RB, Ovsyannikova IG, Poland GA. · · 2021 · cited 5× · PMID 34416408 · DOI 10.1016/j.jaip.2021.08.003
7. Waning immunity and the future of booster vaccination strategies in global vaccine programs post COVID-19.
   Biswas R, Roy A, Kayal T, Basu S, et al · · 2026 · cited 4× · PMID 41656902 · DOI 10.1080/21645515.2026.2626088
8. An overview of the recent findings of cell-based therapies for the treatment and management of COVID-19.
   Ghaffari S, Kazerooni H, Salehi-Najafabadi A. · · 2021 · cited 1× · PMID 34634685 · DOI 10.1016/j.intimp.2021.108226