title: Effect of withholding breastfeeding on the immune response to a live oral rotavirus vaccine in North Indian infants.
abstract: Interference from transplacental and breast milk antibodies may impede the performance of oral live vaccines. The effect of breastfeeding on the immunogenicity of Rotarix, a two-dose oral monovalent rotavirus vaccine, was examined in a community-based trial in New Delhi, India. Four hundred mother-infant pairs were randomized into two equal groups. Infants were aged 6-7 weeks at enrollment. Mothers were encouraged to either breastfeed or to withhold breastfeeding during the 30 min prior to and after each vaccine dose was administered. We collected blood specimens from infants at enrollment and 4 weeks after the second vaccine dose. Blood and breast milk specimens were obtained from mothers at baseline and breast milk specimens were collected at the time of the second vaccine dose. Seroconversion was defined as infant serum anti-VP6 IgA antibody level of ≥20 IU/mL 4 weeks after the second vaccine dose and a ≥4-fold rise from baseline. There was no difference in the proportion who seroconverted between the two groups (26% vs 27%; p=0.92). The levels of infant serum IgA, maternal serum and breast milk IgA and IgG anti-rotavirus antibodies predicted the anti-rotavirus IgA level in infants at end-study and explained approximately 10% of the variability of the immune response (r(2)=0.10, p<0.001). In this population, the immune response to Rotarix was not enhanced by withholding breastfeeding around the time of vaccination. Maternal anti-rotavirus antibodies explained little of the variability in the immune response to the vaccine. Factors other than maternal anti-rotavirus antibodies probably explain why infants in low-and middle-income settings respond poorly to live oral rotavirus vaccines.
authors.affiliation: Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi 110016, India.
authors.forename: Temsunaro
authors.initials: T
authors.lastname: Rongsen-Chandola
authors.affiliation: Innlandet Hospital Trust, Lillehammer, Norway; Centre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Norway. Electronic address: tor.strand@cih.uib.no.
authors.forename: Tor A
authors.initials: TA
authors.lastname: Strand
authors.affiliation: Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi 110016, India.
authors.forename: Nidhi
authors.initials: N
authors.lastname: Goyal
authors.affiliation: Department of Vaccines, Division of Infectious Disease Control, Norwegian Institute of Public Health Oslo, Norway.
authors.forename: Elmira
authors.initials: E
authors.lastname: Flem
authors.affiliation: Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi 110016, India.
authors.forename: Sudeep Singh
authors.initials: SS
authors.lastname: Rathore
authors.affiliation: Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi 110016, India.
authors.forename: Alok
authors.initials: A
authors.lastname: Arya
authors.affiliation: Department of Infectious Diseases Epidemiology, Division of Infectious Disease Control, Norwegian Institute of Public Health Oslo, Norway.
authors.forename: Brita Askeland
authors.initials: BA
authors.lastname: Winje
authors.affiliation: The Wellcome Trust Research Laboratory, Christian Medical College, Vellore 632004, Tamil Nadu, India.
authors.forename: Robin
authors.initials: R
authors.lastname: Lazarus
authors.affiliation: The Wellcome Trust Research Laboratory, Christian Medical College, Vellore 632004, Tamil Nadu, India.
authors.forename: Elango
authors.initials: E
authors.lastname: Shanmugasundaram
authors.affiliation: The Wellcome Trust Research Laboratory, Christian Medical College, Vellore 632004, Tamil Nadu, India.
authors.forename: Sudhir
authors.initials: S
authors.lastname: Babji
authors.affiliation: Department of Vaccines, Division of Infectious Disease Control, Norwegian Institute of Public Health Oslo, Norway; Department of International Public Health, Norwegian Institute of Public Health, Oslo, Norway.
authors.forename: Halvor
authors.initials: H
authors.lastname: Sommerfelt
authors.affiliation: Department of Virology, Division of Infectious Disease Control, Norwegian Institute of Public Health Oslo, Norway.
authors.forename: Kirsti
authors.initials: K
authors.lastname: Vainio
authors.affiliation: The Wellcome Trust Research Laboratory, Christian Medical College, Vellore 632004, Tamil Nadu, India.
authors.forename: Gagandeep
authors.initials: G
authors.lastname: Kang
authors.affiliation: Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi 110016, India.
authors.forename: Nita
authors.initials: N
authors.lastname: Bhandari
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood / Q000737:chemistry; D000917:Antibody Formation; D001942:Breast Feeding; D005260:Female; D006801:Humans; D007112:Immunity, Maternally-Acquired; D007070:Immunoglobulin A / Q000097:blood / Q000737:chemistry; D007074:Immunoglobulin G / Q000097:blood / Q000737:chemistry; D007194:India; D007223:Infant; D008297:Male; D008895:Milk, Human / Q000737:chemistry / Q000276:immunology; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000276:immunology*; D064166:Vaccine Potency; D014613:Vaccines, Attenuated / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D007074:Immunoglobulin G; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: Encouraged breastfeeding; Immune response; Rotarix(®); Rotavirus; Vaccine; Withhold breastfeeding