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NCT07049497: BioVAC-immunit
Study of Immune Response in Subjects Vaccinated Against SARS-CoV-2 Infection
trial testing Evaluation of the T cell response in terms of IFN-γ measured by ELISpot in SAR-CoV-2 in 127 participants. Completed in 15 May 2024.
20 July 2022
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 127 |
| Start date | 28 June 2022 |
| Primary completion | 20 July 2022 |
| Estimated completion | 15 May 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Evaluation of the T cell response in terms of IFN-γ measured by ELISpot
Conditions studied
- SAR-CoV-2 — all drugs for SAR-CoV-2 →
- Cellular Immune Response — all drugs for Cellular Immune Response →
- Antibody Response — all drugs for Antibody Response →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
18 and older, any sex, with SAR-CoV-2 or Cellular Immune Response. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. However, previously infected individuals had stronger and longer-lasting responses. The vaccine induces a Th1-type T cell response, linked to milder disease, and activates follicular helper T cells and B cell responses, although antibody levels drop over time. Immune responses also differ by sex, with females showing stronger humoral responses. Key priorities include understanding humoral fluctuations, characterizing cellular immunity, and correlating both responses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07049497
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07049497 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
- Last refreshed: 14 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07049497.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing