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Virus Vaccine

BBV152 for COVID-19

Phase 2 & 3
Recruiting
Research Sponsored by Ocugen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether the immune response to the vaccine is the same in people in the US as it is in people in India, and whether people who have already received a different vaccine have a different response.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibodies, Blocking
Secondary outcome measures
Evaluate immune-broadening, as measured by MNT neutralizing antibodies, compare the sera taken from previously mRNA or viral vector vaccinated US-based participants with sera taken from previously mRNA or Viral Vector vaccinated placebo controls.
Evaluate potential immune-mediated medical conditions (PIMMCs).
Evaluate response rate of anti-SARS-CoV-2 IgG antibody seroconversion from negative to positive following 28 days of BBV152 administration
+8 more
Other outcome measures
Explore cell based immune response in a subset of participants following 28 days of the second dose of BBV152 administration
Explore the immunogenicity of one and two doses of BBV152 against future variants of concern.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BBV152Active Control1 Intervention
BBV152
Group II: PlaceboPlacebo Group1 Intervention
0.9% normal saline

Find a Location

Who is running the clinical trial?

OcugenLead Sponsor
9 Previous Clinical Trials
667 Total Patients Enrolled
1 Trials studying COVID-19
Huma Qamar, MD, MPH, CMIStudy DirectorOcugen
3 Previous Clinical Trials
229 Total Patients Enrolled

Media Library

BBV152 (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05258669 — Phase 2 & 3
COVID-19 Research Study Groups: BBV152, Placebo
COVID-19 Clinical Trial 2023: BBV152 Highlights & Side Effects. Trial Name: NCT05258669 — Phase 2 & 3
BBV152 (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05258669 — Phase 2 & 3
COVID-19 Patient Testimony for trial: Trial Name: NCT05258669 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are helping to test this new medication?

"The information available on clinicaltrials.gov verifies that this research is still looking for volunteers. The trial was initially advertised on February 20th, 2022 and updated for the last time on August 30th of the same year. In total, 400 individuals are needed to complete the study at 9 different locations."

Answered by AI

Is this trial being conducted in numerous hospitals throughout the state?

"Currently, this trial is taking place in 9 locations which include Dallas, Tempe and Winter Park. If you are considering enrolling in the trial, please pick a clinic that is most convenient for you to attend to minimize travel requirements."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
PRX Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I haven't tried any other meds for this.
PatientReceived 2+ prior treatments
~130 spots leftby Mar 2025