Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in Five Countries in Africa.

Africa Rotavirus intussusception rotavirus vaccine vaccine safety

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
19 Aug 2023
Historique:
received: 15 06 2023
revised: 07 08 2023
accepted: 16 08 2023
medline: 19 8 2023
pubmed: 19 8 2023
entrez: 19 8 2023
Statut: aheadofprint

Résumé

A low-level risk of intussusception following rotavirus vaccination has been observed in some settings and may vary by vaccine type. We examined the association between RotaTeq vaccination and intussusception in low-income settings in a pooled analysis from five African countries that introduced RotaTeq into their national immunization program. Active surveillance was conducted in 20 sentinel sites to identify intussusception cases. A standard case report form was completed for each enrolled child and vaccination status was determined by review of the child's vaccination card or clinic record. The pseudo-likelihood adaptation of self-controlled case-series method was used to assess the association between RotaTeq administration and intussusception in the 1-7, 8-21, and 1-21 day periods after each vaccine dose in infants 28 to 245 days of age. Data from 318 infants with confirmed rotavirus vaccination status were analyzed. No clustering of cases occurred in any of the risk windows after any of the vaccine doses. Compared to the background risk of naturally occurring intussusception, no increased risk was observed after dose 1 in the 1-7 day (relative incidence=2.71, 95% confidence interval (CI)=0.47-8.03) or the 8-21 day window (relative incidence=0.77, 95%CI=0.0-2.69). Similarly, no increased risk of intussusception was observed in any risk window after dose 2 or dose 3. RotaTeq vaccination was not associated with an increased risk of intussusception in this pooled analysis from five African countries. This finding mirrors what was reported in similar analyses with other rotavirus vaccines in low-income settings and highlights need for vaccine-specific and setting-specific risk monitoring.

Sections du résumé

BACKGROUND BACKGROUND
A low-level risk of intussusception following rotavirus vaccination has been observed in some settings and may vary by vaccine type. We examined the association between RotaTeq vaccination and intussusception in low-income settings in a pooled analysis from five African countries that introduced RotaTeq into their national immunization program.
METHODS METHODS
Active surveillance was conducted in 20 sentinel sites to identify intussusception cases. A standard case report form was completed for each enrolled child and vaccination status was determined by review of the child's vaccination card or clinic record. The pseudo-likelihood adaptation of self-controlled case-series method was used to assess the association between RotaTeq administration and intussusception in the 1-7, 8-21, and 1-21 day periods after each vaccine dose in infants 28 to 245 days of age.
RESULTS RESULTS
Data from 318 infants with confirmed rotavirus vaccination status were analyzed. No clustering of cases occurred in any of the risk windows after any of the vaccine doses. Compared to the background risk of naturally occurring intussusception, no increased risk was observed after dose 1 in the 1-7 day (relative incidence=2.71, 95% confidence interval (CI)=0.47-8.03) or the 8-21 day window (relative incidence=0.77, 95%CI=0.0-2.69). Similarly, no increased risk of intussusception was observed in any risk window after dose 2 or dose 3.
CONCLUSIONS CONCLUSIONS
RotaTeq vaccination was not associated with an increased risk of intussusception in this pooled analysis from five African countries. This finding mirrors what was reported in similar analyses with other rotavirus vaccines in low-income settings and highlights need for vaccine-specific and setting-specific risk monitoring.

Identifiants

pubmed: 37596934
pii: 7246285
doi: 10.1093/cid/ciad492
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : World Health Organization
ID : 001
Pays : International

Informations de copyright

Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.

Auteurs

Jacqueline E Tate (JE)

U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States.

Jason M Mwenda (JM)

World Health Organization Regional Office for Africa, Brazzaville, Congo.

Adama Mamby Keita (AM)

Center for Vaccine Development, Bamako, Mali.

Toussaint Wendlamita Tapsoba (TW)

Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle, Ouagadougou, Burkina Faso.

Edouard Ngendahayo (E)

King Faisal Hospital, Kigali, Rwanda.

Bertin Dibi Kouamé (BD)

University Hospital of Yopougon, Abidjan, Cote d'Ivoire.

Ahmadou Lamin Samateh (AL)

Ministry of Health, Banjul, The Gambia.

Negar Aliabadi (N)

U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States.

Seydou Sissoko (S)

Center for Vaccine Development, Bamako, Mali.

Yacouba Traore (Y)

Centre Hospitalier Universitaire Sourou SANOU de Bobo Dioulasso, Bobo Dioulasso, Burkina Faso.

Justin Bayisenga (J)

University Teaching Hospital of Butare, Butare, Rwanda.

Moufidath Sounkere-Soro (M)

University Hospital of Yopougon, Abidjan, Cote d'Ivoire.

Sheriffo Jagne (S)

National Public Health Reference Laboratory, Ministry of Health, Banjul, The Gambia.

Rachel M Burke (RM)

U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States.

Uma Onwuchekwa (U)

Center for Vaccine Development, Bamako, Mali.

Ma Ouattara (M)

World Health Organization Country Office, Ouagadougou, Burkina Faso.

Joel B Bikoroti (JB)

University Teaching Hospital of Kigali, Kigali, Rwanda.

Kofi N'Zue (K)

World Health Organization Country Office, Abidjan, Cote d'Ivoire.

Eyal Leshem (E)

U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States.

Oumar Coulibaly (O)

Centre Hospitalier Universitaire Gabriel Touré, Bamako, Mali.

Issa Ouedraogo (I)

Ministry of Health, Expanded Program on Immunizations, Ouagadougou, Burkina Faso.

Jeannine Uwimana (J)

University Teaching Hospital of Kigali, Kigali, Rwanda.

Samba Sow (S)

Center for Vaccine Development, Bamako, Mali.

Umesh D Parashar (UD)

U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States.

Classifications MeSH