TY - JOUR
T1 - Evaluation of ROTARIX® Booster Dose Vaccination at 9 Months for Safety and Enhanced Anti-Rotavirus Immunity in Zambian Children
T2 - A Randomised Controlled Trial
AU - Laban, Natasha Makabilo
AU - Bosomprah, Samuel
AU - Simuyandi, Michelo
AU - Chibuye, Mwelwa
AU - Chauwa, Adriace
AU - Chirwa-Chobe, Masuzyo
AU - Sukwa, Nsofwa
AU - Chipeta, Chikumbutso
AU - Velu, Rachel
AU - Njekwa, Katanekwa
AU - Mubanga, Cynthia
AU - Mwape, Innocent
AU - Goodier, Martin Rhys
AU - Chilengi, Roma
N1 - Funding Information: This study is part of the EDCTP2 programme supported by the European Union (grant number TMA2016SF-1511-ROVAS-2). This work was also supported by the Wellcome Trust [211356/Z/18/Z]. Publisher Copyright: © 2023 by the authors.
PY - 2023/2/3
Y1 - 2023/2/3
N2 - Oral rotavirus vaccines show diminished immunogenicity in low-resource settings where rotavirus burden is highest. This study assessed the safety and immune boosting effect of a third dose of oral ROTARIX® (GlaxoSmithKline) vaccine administered at 9 months of age. A total of 214 infants aged 6 to 12 weeks were randomised to receive two doses of ROTARIX® as per standard schedule with other routine vaccinations or an additional third dose of ROTARIX® administered at 9 months old concomitantly with measles/rubella vaccination. Plasma collected pre-vaccination, 1 month after first- and second-dose vaccination, at 9 months old before receipt of third ROTARIX® dose and/or measles/rubella vaccination, and at 12 months old were assayed for rotavirus-specific IgA (RV-IgA). Geometric mean RV-IgA at 12 months of age and the incidence of clinical adverse events 1 month following administration of the third dose of ROTARIX® among infants in the intervention arm were compared between infants in the two arms. We found no significant difference in RV-IgA titres at 12 months between the two arms. Our findings showed that rotavirus vaccines are immunogenic in Zambian infants but with modest vaccine seroconversion rates in low-income settings. Importantly, however, a third dose of oral ROTARIX® vaccine was shown to be safe when administered concomitantly with measles/rubella vaccine at 9 months of age in Zambia. This speaks to opportunities for enhancing rotavirus vaccine immunity within feasible schedules in the national immunization program.
AB - Oral rotavirus vaccines show diminished immunogenicity in low-resource settings where rotavirus burden is highest. This study assessed the safety and immune boosting effect of a third dose of oral ROTARIX® (GlaxoSmithKline) vaccine administered at 9 months of age. A total of 214 infants aged 6 to 12 weeks were randomised to receive two doses of ROTARIX® as per standard schedule with other routine vaccinations or an additional third dose of ROTARIX® administered at 9 months old concomitantly with measles/rubella vaccination. Plasma collected pre-vaccination, 1 month after first- and second-dose vaccination, at 9 months old before receipt of third ROTARIX® dose and/or measles/rubella vaccination, and at 12 months old were assayed for rotavirus-specific IgA (RV-IgA). Geometric mean RV-IgA at 12 months of age and the incidence of clinical adverse events 1 month following administration of the third dose of ROTARIX® among infants in the intervention arm were compared between infants in the two arms. We found no significant difference in RV-IgA titres at 12 months between the two arms. Our findings showed that rotavirus vaccines are immunogenic in Zambian infants but with modest vaccine seroconversion rates in low-income settings. Importantly, however, a third dose of oral ROTARIX® vaccine was shown to be safe when administered concomitantly with measles/rubella vaccine at 9 months of age in Zambia. This speaks to opportunities for enhancing rotavirus vaccine immunity within feasible schedules in the national immunization program.
KW - Africa
KW - ROTARIX
KW - Zambia
KW - booster dose
KW - immunogenicity
KW - rotavirus
KW - safety
KW - vaccine
UR - http://www.scopus.com/inward/record.url?scp=85149118176&partnerID=8YFLogxK
U2 - https://doi.org/10.3390/vaccines11020346
DO - https://doi.org/10.3390/vaccines11020346
M3 - Article
C2 - 36851224
SN - 2076-393X
VL - 11
JO - Vaccines
JF - Vaccines
IS - 2
M1 - 346
ER -