Fractional BNT162b2 Booster Immunogenicity Trial in Mongolia

A clinical trial dataset from Mongolia contains immunogenicity and safety data for 601 participants over 24 months. It compares 15 μg and 30 μg BNT162b2 booster doses in adults primed with non-mRNA COVID-19 vaccines. The data includes anti-spike IgG, surrogate virus neutralization, and interferon-gamma release assay results.

Use Cases

• Compare anti-spike IgG geometric mean ratios between the 15 μg and 30 μg BNT162b2 booster arms over 24 months.
• Analyze surrogate virus neutralization (sVNT) inhibition percentages against Wuhan-Hu-1 and Omicron BA.1 variants across study participants.
• Assess the correlation between interferon-gamma (IFN-γ) release assay results (Ag1/Ag2) and recorded SARS-CoV-2 infection events.
• Evaluate the distribution of 53 serious adverse events (SAEs) by study arm to confirm safety balance.

Strengths

• Contains data from 601 participants with 520 (86.5%) completing the 24-month follow-up, providing longitudinal immunogenicity tracking.
• Includes multiple immunogenicity metrics: anti-spike IgG, surrogate virus neutralization against two variants, and interferon-gamma release assays.
• Data originates from a registered, randomized controlled trial (NCT05265065) with a clear methodology.

Limitations

• The dataset is small in scale (1014.7 KB), likely containing summary results rather than granular, row-level participant data.
• Geographic focus is limited to Mongolia, which may limit generalizability to other populations.
• Data is presented in a DOCX file format, which is not ideal for direct computational analysis and may require manual extraction.

Provenance

Source

ClinicalTrials.gov study NCT05265065, published via figshare.

Collection Method

Randomized controlled trial.

Time Range

24-month follow-up period.

Freshness

Last updated on 2026-03-23.

Geography

Mongolia.