Figure 1.
Studies on RSV Vaccine Development and Efficacy in Infants and Children
| Study ID | Type of Active Immunizing Agent | Population | Study Design | Conclusion |
|---|---|---|---|---|
| Cunningham et al, 202022 | Live Attenuated Vaccine | 6–24 months | Randomized control trial | Two candidate vaccines were compared: RSV/ΔNS2/Δ1313/I1314L and RSV/276. Both vaccines were well tolerated, highly infectious, and immunogenic in children, showing potential for RSV vaccination in children aged 6–24 months. |
| McFarland et al, 201823 | Live Attenuated Vaccine | 6–24 months | Randomized control trial | The LID ΔM2-2 vaccine demonstrated good infectivity and immunogenicity in RSV-seronegative children, with a ≥4-fold increase in antibody levels and good protection in the subsequent RSV season. |
| McFarland et al, 202024 | Live Attenuated Vaccine | 6–24 months | Randomized control trial | The LID/ΔM2-2/1030s vaccine demonstrated high immunogenicity, with 95% of participants showing a ≥4-fold increase in serum RSV-neutralizing antibody levels. |
| Malkin et al, 201325 | Live Attenuated Vaccine | 6–24 months | Randomized control trial | MEDI-559 (live attenuated intranasal vaccine) showed good safety and sero-response (59% of recipients). It was well tolerated with mild and moderate side effects. |
| Belshe RB et al, 198215 | Live Attenuated Vaccine | Children under 24 months | Field trial | The live RSV vaccine administered parenterally was ineffective in preventing RSV infection during epidemics, highlighting challenges with live vaccine formulations. |
| Groothuis JR et al, 199816 | Subunit-Based Vaccine (Purified F protein) | Children under 12 months with bronchopulmonary dysplasia | Clinical trial | The purified F protein RSV vaccine (PFP-2) demonstrated safety, immunogenicity, and potential protection against severe RSV disease in children with bronchopulmonary dysplasia. |
| Tristram DA et al, 199317 | Subunit-Based Vaccine (F glycoprotein) | Children 18–36 months (seropositive for RSV) | Clinical trial | The F glycoprotein-based subunit vaccine showed promising results in preventing subsequent RSV infections in children who had previously been hospitalized for RSV without significant side effects. |
| Kim HW et al, 196918 | Inactivated Vaccine (FI-RSV) | Infants and young children | Clinical trial | Infants vaccinated with FI-RSV had a significantly higher risk of severe disease and hospitalization when later infected with RSV, leading to fatalities in two cases. |
| Graham BS, 201719 | Review (Live Attenuated, Chimeric Virus Vaccines) | N/A | Review | Live attenuated and live chimeric RSV vaccines are among the most promising candidates. Studies show that, unlike inactivated vaccine formulations, they do not trigger enhanced disease. |
| Tang RS et al, 200820 | Vector-Based Vaccine (PIV-Vectored RSV Vaccine) | Healthy adults | Preclinical and initial clinical trial | The PIV-vectored RSV vaccine was tested for safety and enhanced disease in healthy adults. It showed promise in the preclinical phase but required further investigation for broader use. |
| Wright PF et al, 200721 | Live Attenuated Vaccine | Children | Clinical trial | Live attenuated RSV vaccines did not cause enhanced disease after exposure to wild-type RSV, suggesting their potential safety in preventing RSV infections. |
Studies on RSV Vaccination to Mothers During Pregnancy
| Study ID | Country | Study Design | Conclusion |
|---|---|---|---|
| Madhi et al, 202039 | multicenter | Randomized control trial | The maternal RSV-F nanoparticle vaccine showed 40% efficacy against medically significant RSV lower respiratory infection in infants under 90 days, with variation between lower-middle-income countries (LMIC) and high-income countries (HIC) and had a good safety profile. |
| Bebia et al, 202340 | multicenter | Phase 2 Randomized Trial | RSVPreF3 vaccine administered to pregnant women in the late second or third trimester showed a safe profile, robust immune response, successful antibody transfer to infants, and antibody persistence for at least six months post-birth. |
| Kampmann et al, 202341 | multicenter | Randomized control trial | The trial investigated the effects of RSVpreF in over 3000 pregnant women and their infants. The vaccine demonstrated over 80% efficacy against severe illness within 90 days of birth and approximately 69% efficacy against severe illness within 180 days of birth. |