Trial NCT04641481
Publication Ella R, Lancet, 2021
Dates: 2020-11-16 to 2021-01-07
Funding: Mixed (Bharat Biotech International Limited and the Indian Council of Medical Research.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / India Follow-up duration (months): 12 | |
| BBV152B (n=12,899) Placebo (n=12,899) |
|
| Inclusion criteria | Ability to provide written informed consent and availability to fulfill the study requirement; Participants of either gender of aged 18 years and above; Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment; For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least eight weeks after the last vaccination; Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination; Agrees not to participate in another clinical trial at any time during the study period; Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study; Agrees to remain in the study area for the entire duration of the study; Willing to allow storage and future use of biological samples for future research |
| Exclusion criteria | History of any other COVID-19 investigational or licensed vaccination; Known history of SARS-CoV-2 infection, as declared by the subject; For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period; Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine; Resident of COVID-19 infection in the same household; Known case of HIV, hepatitis B, or hepatitis C infection; Receipt of any licensed/experimental vaccine within four weeks before enrolment in this study; Receipt of immunoglobulin or other blood products within the three months before vaccination in this study; Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months; Immunoglobulins, anti-cytokine antibodies, and blood products within 6 months prior to study vaccination, during, and 21 days following the last dose of vaccination; Pregnancy, lactation, or willingness/intention to become pregnant during the first 6 months after enrolment; Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed) |
| Interventions | |
| Intervention
2 IM doses of 6 mcg, 28 days apart |
|
| Control
2 IM doses of placebo, 28 days apart | |
| Participants | |
| Randomized 25798 participants | |
| Characteristics of participants Type of participants: Adults N=25798 17285 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 18-92 | |
| Description of participants Adults with no history of SARS-CoV-2 infection who were healthy or had stable chronic medical conditions at 25 centers in India | |
| Primary outcome | |
| In the register First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19. [ Time Frame: Day 42 to Month 12 ] (RT-PCR positive) symptomatic cases of COVID-19. | |
| In the report Efficacy of the BBV152 vaccine in preventing a first occurrence of symptomatic COVID-19(any severity)with onset at least 14 days after the second dose in the per-protocol populationcomposed of participants who were SARS-CoV-2 negative by PCR and serology at baseline,had no major protocol deviations, and followed-up for at least two weeks after the second dose. | |
| Variants description | |
Variants
| |
| Description Alpha (B.1.1.7), B.1.1.28, B.1.617.1, B.1.351 (Gamma), and B.1.617.2 (Delta) variants | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, When the trial is complete upon direct request to the corresponding author with an appropriate research proposal. |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Variant delta: Some concerns Variant alpha: Some concerns |
| General comment | In addition to the pre-print article, the study registry, protocol andstatistical plan were used in the data extraction and risk assessment. Target sample size was achieved. There is not change from the trial registration in the intervention and control treatments. The outcome "The occurrence of enhanced respiratory disease episodes. " is present in the registry but not reported.sAb GMT was not included in the listed outcomes in the registry, but included as an outcome in the detailed description above, along with the small subgroup that immunogenicity was evaluated amongst. ) Mortality was not included in the listed outcomes in the registry, but evaluated as a SAE in the safety population. This trial was updated on Mars 3rd, 2022 after study report publication. |