Sputnik V XBB Vaccine Clinical Trial Safety and Immunogenicity Data

Data Sheet 1_Sputnik V update contains results from two open prospective clinical studies on the Gam-COVID-Vac XBB vaccine. The studies involved 50 adult participants over 18 years old and 50 adolescent participants aged 12–17 years. It reports safety, reactogenicity, and immunogenicity data, including seroconversion rates and neutralizing antibody responses against multiple SARS-CoV-2 variants.

Use Cases

• Compare seroconversion rates of antigen-specific IgG between adult and adolescent cohorts from the clinical trial results.
• Analyze neutralizing antibody (NtAb) response levels against variants like XBB.1.5, JN.1, and BA.2.86 reported in the immunogenicity study.
• Assess the safety profile and incidence of serious adverse events (AEs) documented across the 100 total participants.
• Model immunogenicity outcomes such as NtAb seroconversion rates (96% in adults, 94% in adolescents) against circulating SARS-CoV-2 variants.

Strengths

• Includes immunogenicity data against 10 specific SARS-CoV-2 variants (e.g., XBB.1.5, EG.5.1, JN.1).
• Reports results from a controlled clinical trial with 100 total participants (50 adults, 50 adolescents).
• Provides precise seroconversion rates (100% IgG in adults, 87.5% in adolescents; 96% NtAb in adults, 94% in adolescents).
• Linked to registered clinical trials (NCT06068569 and NCT06068556) with a clear methodology description.

Limitations

• Dataset is a 20.3 KB DOCX file, containing summarized results rather than raw, structured tabular data.
• Sample size is limited to 100 participants, which may restrict statistical power for subgroup analyses.
• Geographic and demographic specifics of the participant population are not detailed in the provided description.

Provenance

Source

Inna V. Shuliakova via figshare.

Collection Method

Data from two open prospective clinical studies conducted by Gamaleya NRCEM (Moscow, Russia).

Time Range

Study period not specified; results published in 2026.

Freshness

Last updated March 26, 2026.

Geography

Study location not explicitly stated; conducted by a Russian research center.