NCT05047718: COVIMMUNAGE

Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19

Completed Phase 4 Last updated 11 December 2024

What this trial tests

Phase 4 trial testing COVID-19 vaccine Pfizer (3 doses) in Covid19 in 54 participants. Completed in 28 February 2023.

Timeline

5 October 2021

Primary endpoint
29 August 2022

28 February 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	54
Start date	5 October 2021
Primary completion	29 August 2022
Estimated completion	28 February 2023
Sites	2 locations across France

Drugs / interventions tested

• COVID-19 vaccine Pfizer (3 doses) — full drug profile →
• COVID-19 vaccine Pfizer (2 doses) — full drug profile →
• COVID-19 mRNA Vaccine Moderna (3 doses) — full drug profile →
• COVID-19 mRNA Vaccine Moderna (2 doses) — full drug profile →
• COVID-19 mRNA Vaccine Moderna (1 dose) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.

Publications & conference data

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

1. COVID-19 vaccine development: milestones, lessons and prospects.
   Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y
2. Nanoparticles in clinical trials of COVID-19: An update.
   Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
3. COVID-19 phase 4 vaccine candidates, effectiveness on SARS-CoV-2 variants, neutralizing antibody, rare side effects, traditional and nano-based vaccine platforms: a review.
   Simnani FZ, Singh D, Kaur R. · · 2022 · cited 18× · PMID 34926119 · DOI 10.1007/s13205-021-03076-0
4. Understanding the challenges to COVID-19 vaccines and treatment options, herd immunity and probability of reinfection.
   Al-Hatamleh MAI, Abusalah MA, Hatmal MM, Alshaer W, et al · · 2023 · cited 7× · PMID 36570799 · DOI 10.1016/j.jtumed.2022.11.007
5. Current clinical status of new COVID-19 vaccines and immunotherapy.
   Nagpal D, Nagpal S, Kaushik D, Kathuria H. · · 2022 · cited 6× · PMID 36063274 · DOI 10.1007/s11356-022-22661-1