From the Guidelines
Yes, there are double-blind randomized controlled trials (RCTs) for RSV vaccines, as evidenced by the recent studies on Pfizer's RSVpreF (Abrysvo) and GSK's RSVPreF3 (Arexvy) 1. These trials typically involved tens of thousands of participants who received either the vaccine or a placebo, with neither the participants nor the researchers knowing who received which until the study concluded. The trials measured outcomes such as prevention of RSV-associated lower respiratory tract disease and hospitalization rates. For example, Pfizer's maternal RSV vaccine trial showed approximately 82% efficacy in preventing severe RSV in infants during their first 90 days of life, as reported in a position paper from the Portuguese Society of Pulmonology 1. The GSK vaccine for older adults demonstrated about 83% efficacy against RSV-associated lower respiratory disease. These double-blind RCTs were essential in establishing both the safety profiles and efficacy of these vaccines before they received regulatory approval for public use. Some key points about the RSV vaccines include:
- Indication: Active immunisation for the prevention of LRTD caused by RSV in adults aged ≥60 years and in adults aged 50–59 years at increased risk for RSV disease 1
- Posology and administration: Single dose, intramuscular injection 1
- Season 1 efficacy in adults ≥60 years old: RSV-associated LRTD: 82.6 (96.95% CI: 57.9,94.1) for the Recombinant RSV pre-fusion F protein adjuvanted with AS0148 vaccine 1 The Advisory Committee on Immunization Practices (ACIP) has recommended that adults aged ≥60 years may receive a single dose of RSV vaccine, using shared clinical decision-making 1.
From the FDA Drug Label
The safety and efficacy of Synagis were assessed in two randomized, double-blind, placebo-controlled trials of prophylaxis against RSV infection in children at high risk of an RSV-related hospitalization
- Double-blind RCTs: Yes, there are double-blind Randomized Controlled Trials (RCT) for Respiratory Syncytial Virus (RSV) vaccine, specifically for the drug Synagis (palivizumab).
- Key points:
- Two trials were conducted: Trial 1 and Trial 2.
- Both trials were randomized, double-blind, and placebo-controlled.
- The trials assessed the safety and efficacy of Synagis in preventing RSV infection in high-risk children. 2
From the Research
RSV Vaccine Double-Blind Randomized Controlled Trials (RCT)
- There are double-blind RCTs for Respiratory Syncytial Virus (RSV) vaccine, as seen in the following studies:
- A phase 2b study, CYPRESS, which evaluated the efficacy of Ad26.RSV.preF-RSV preF protein vaccine over three RSV seasons 3
- A phase 3 study that demonstrated equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age 4
- A phase I, randomized, double-blind, placebo-controlled trial that assessed the safety and immunogenicity of a novel mucosal RSV F protein vaccine linked to an immunostimulatory bacterium-like particle (BLP) 5
- These studies indicate that double-blind RCTs have been conducted to evaluate the safety, efficacy, and immunogenicity of various RSV vaccine candidates.
Study Details
- The CYPRESS study was a randomized, double-blind, placebo-controlled, phase 2b study that evaluated the efficacy of Ad26.RSV.preF-RSV preF protein vaccine over three RSV seasons 3
- The phase 3 study was a multicenter, parallel-group, placebo-controlled, randomized (1:1:1:1), double-blind study that evaluated immunogenicity, safety, and tolerability of RSVpreF in healthy 18-49-year-old adults 4
- The phase I trial was a randomized, double-blind, placebo-controlled trial that assessed the safety and immunogenicity of a novel mucosal RSV F protein vaccine linked to an immunostimulatory bacterium-like particle (BLP) in healthy volunteers aged 18-49 years 5
Key Findings
- The CYPRESS study found that Ad26.RSV.preF-RSV preF protein maintained high efficacy against RSV LRTD in older adults across three RSV seasons 3
- The phase 3 study demonstrated equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age 4
- The phase I trial found that the novel mucosal RSV F protein vaccine induced systemic plasmablast responses and significant, durable increases in RSV-specific serum antibody in healthy, seropositive adults 5