EFFICACY OF THE MEASLES-MUMPS-RUBELLA (MMR) VACCINE IN THE REDUCING THE SEVERITY OF COVID-19: AN INTERIM ANALYSIS OF A RANDOMISED CONTROLLED CLINICAL TRIAL
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- Evaluated articles (Rapid Reviews Infectious Diseases)
Abstract
Background
COVID-19 is still a challenge, both with regard to its treatment and to the actual efficacy of the vaccines available to date, especially with the emergence of new variants. We evaluated the efficacy of the measles-mumps-rubella (MMR) vaccine in preventing SARS-CoV-2 infection and severity of COVID-19 in health workers.
Methods
This analysis includes data from one ongoing blinded, randomized, placebo-controlled trial with participants aged 18-60 years were randomly assigned to receive the MMR vaccine or a placebo. The primary efficacy analysis included all participants with a positive nasopharyngeal RT-PCR test since their inclusion.
Results
The MMR vaccine did not prevent the SARS-CoV-2 infection. Participants in the MMR group, compared with those in the placebo group, had a 48% risk reduction in symptomatic COVID-19 (RR = 0.52; 95% CI: 0.33–0.83; p=0.004) and a 76% risk reduction in COVID-19 treatment (RR = 0.24; 95% CI: 0.06 – 0.88; p = 0.020) with one dose and a 51% risk reduction in COVID-19 symptoms (RR = 0.49; 95% CI: 0.31 – 0.78; p = 0.001) and a 78% risk reduction in COVID-19 treatment (RR = 0.22; 95% CI: 0.06 – 0.82; p = 0.015) with two doses.
Conclusions
This interim analysis of an ongoing clinical trial suggests that compared with a placebo, the vaccine reduces the risk of COVID-19 symptoms and reduces the need for COVID-19 treatment.
Clinical Trials Registry
Brazilian Clinical Trials Registry (ReBEC n° RBR-2xd6dkj - https://ensaiosclinicos.gov.br/rg/RBR-2xd6dkj ).
HIGHLIGHTS
The MMR vaccine can stimulate the innate immunity inducing a nonspecific protection against other infections, called heterologous immunity.
Repeated exposure to the antigen (innate immune response training) results in an extension of the action time of this immune response (innate immune response memory) and consequently in protection against other infections (heterologous immunity) for a longer time.
The MMR vaccine has been used by national immunization programs in the world for many years, it is very safe and can be stored and distributed at 2-8°C, making it particularly suitable for global distribution.
Among participants who received at least one dose, compared with those in the placebo group, participants in the MMR group had a significant risk reduction in symptomatic COVID-19 and of cases requiring treatment.
The use of MMR vaccine can be useful in several populations in the world that do not have access to the COVID-19 vaccine and in a future epidemic or pandemic as an emergency measure until specific treatments or vaccines for each case are available to the general population.
Article activity feed
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Francisco Javier Garcia-Martinez
Review 2: "Efficacy of the Measles-Mumps-Rubella(MMR) Vaccine in the Reducing the Severity of COVID-19: An Interim Analysis of a Randomised Controlled Clinical Trial"
This preprint claims that the MMR vaccine offers some protection against COVID-19, but does not decrease risk of infection. While the claims are potentially informative and supportive of similar studies, large potential biases exist in the study that need to be addressed.
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Shymasundaran Kottilil
Review 1: "Efficacy of the Measles-Mumps-Rubella(MMR) Vaccine in the Reducing the Severity of COVID-19: An Interim Analysis of a Randomised Controlled Clinical Trial"
This preprint claims that the MMR vaccine offers some protection against COVID-19, but does not decrease risk of infection. While the claims are potentially informative and supportive of similar studies, large potential biases exist in the study that need to be addressed.
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Strength of evidence
Reviewers: S Kottilil (Institute of Human Virology) | 📒📒📒 ◻️◻️
F Garcia-Martinez (Clínica Universidad de Navarra) | 📗📗📗📗◻️ -
SciScore for 10.1101/2021.09.14.21263598: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by Ethics Committees of Federal University of Santa Catarina (n° 4.254.143) and National Research Ethics Committee (n° 4.274.984).
Consent: All participants gave written informed consent. 2.2.Sex as a biological variable All study volunteers met all of the following criteria to participate in the study (inclusion criteria): 1) male and female health workers aged 18 to 60 years (inclusive) at the first visit (V1); 2) volunteers who, in the opinion of the researchers, were able to meet the requirements of the study protocol. Randomization Study design and participants: This is a randomized, double-blind, placebo-controlled, phase 3, clinical … SciScore for 10.1101/2021.09.14.21263598: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by Ethics Committees of Federal University of Santa Catarina (n° 4.254.143) and National Research Ethics Committee (n° 4.274.984).
Consent: All participants gave written informed consent. 2.2.Sex as a biological variable All study volunteers met all of the following criteria to participate in the study (inclusion criteria): 1) male and female health workers aged 18 to 60 years (inclusive) at the first visit (V1); 2) volunteers who, in the opinion of the researchers, were able to meet the requirements of the study protocol. Randomization Study design and participants: This is a randomized, double-blind, placebo-controlled, phase 3, clinical trial to evaluate efficacy of the MMR vaccine against SARS-CoV-2 induced COVID-19 in health workers from Florianópolis, Brazil, seen at the University Hospital at Federal University of Santa Catarina. Blinding Randomisation and blinding: A total of 430 health workers were included in the study. Power Analysis Statistical analysis: Assuming an expected infection rate of 20% in the group not exposed to vaccination and 10% in the vaccinated group, with an alpha error of 5%, power of 80%, and group ratio of 1.5:1, the calculated minimum sample size required was 405 volunteers. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:This study had some limitations. Although the number of participants was small, the median follow-up of five months was sufficient for a statistical analysis to demonstrate significance. A second issue to address is the duration of the action of the MMR vaccine in COVID-19 disease progression. We still do not know how long it lasts, but the study is still ongoing to try to answer this question. It would be extremely important to have evaluated the cellular immune response and viral load between the vaccinees and placebo, as this would be an indicator of the effectiveness of MMR vaccine in inducing innate immune responses that could reduce viral load. We were unable to conducted genetic sequencing of suspected cases of reinfection due to laboratory challenges. We did not have information on the dosages of antibodies in the individuals who developed COVID-19 and were vaccinate or not with MMR. It was not possible to perform the genotyping of Sars-CoV-2 in infected patients to assess the possible variants. The age range evaluated was 18-60 years, and we cannot guarantee that the observed results will be the same in people above and below these ages. The results of the trial were obtained from health workers, who are generally healthy and it is not possible to extrapolate these same results to the general population.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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