Immunogenicity of a live-attenuated human rotavirus RIX4414 vaccine with or without buffering agent

A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India

“…The results of this study in terms of the role of the buffer on vaccine performance confirm and extend those of earlier studies that examined the role of buffer with the other licensed RV vaccine. 18 If a separate or combined buffer is not required by health workers at peripheral health facilities, many important programmatic issues, such as incorrect reconstitution of a vaccine, temporary unavailability of the buffer, reduction of the cold chain footprint, waste management after each vaccination session, and finally conformance to WHO Pre-Qualification requirements, are addressed. Major health systems costs such as transport and logistics, 19 can also be reduced.…”

“…However, licensed RV vaccines reported no difference in immune responses from buffered and un-buffered vaccines. 17 , 18 These licensed vaccines use buffering components to minimize vaccine virus degradation in the stomach, and pose several logistic and programmatic challenges in terms of either having to separately transport and store the buffering diluent, and administer relatively large volumes (1.5 to 2.5 mL) of reconstituted or ready-to-use vaccine orally to infants. From a vaccine administration point of view for infants, low dose volumes are preferred.…”

Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37°C for seven days

“…The data from Groups RIX4414_ control, RIX4414_37°C and Placebo are presented and discussed in this manuscript; the data from the other groups has been presented elsewhere. 14 Infants who had received any other investigational drug or vaccine or had a history of gastrointestinal disease or rotavirus gastroenteritis, were allergic to any of the vaccine components or had a history of immunosuppressive or immunodeficient condition were excluded from participating in the study.…”

Investigation of a regulatory agency enquiry into potential porcine circovirus type 1 contamination of the human rotavirus vaccine,Rotarix™

“…In three of the studies, infants were required to be healthy at trial entry. [62][63][64] The fourth study evaluated Rotarix™ administration in HIVpositive infants. 65 This study was specifically included since it was speculated that if replication of PCV1 were to occur, it might be enhanced in immunocompromised infants.…”

“…Table 4 provides an overview of the four selected Rotarix™ studies (NCT00169455, NCT00137930, NCT00757770, and NCT00263666). [62][63][64][65] The studies were conducted in Asia, Europe, Latin America and Africa. In three of the studies, infants were required to be healthy at trial entry.…”