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Reduced Mortality After Oral Polio Vaccination and Increased Mortality After Diphtheria- Tetanus-Pertussis Vaccination in Children in a Low-Income Setting

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Reduced Mortality After Oral Polio Vaccination and Increased Mortality After Diphtheria- Tetanus-Pertussis Vaccination in Children in a Low-Income Setting University of Southern Denmark Reduced Mortality After Oral Polio Vaccination and Increased Mortality After Diphtheria- Tetanus-Pertussis Vaccination in Children in a Low-Income Setting Øland, Christian Bjerregård; Mogensen, Søren Wengel; Rodrigues, Amabelia; Benn, Christine S.; Aaby, Peter Published in: Clinical Therapeutics DOI: 10.1016/j.clinthera.2020.11.010 Publication date: 2021 Document version: Final published version Document license: CC BY-NC-ND Citation for pulished version (APA): Øland, C. B., Mogensen, S. W., Rodrigues, A., Benn, C. S., & Aaby, P. (2021). Reduced Mortality After Oral Polio Vaccination and Increased Mortality After Diphtheria-Tetanus-Pertussis Vaccination in Children in a Low- Income Setting. Clinical Therapeutics, 43(1), 172-184.e7. https://doi.org/10.1016/j.clinthera.2020.11.010 Go to publication entry in University of Southern Denmark's Research Portal Terms of use This work is brought to you by the University of Southern Denmark. Unless otherwise specified it has been shared according to the terms for self-archiving. If no other license is stated, these terms apply: • You may download this work for personal use only. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying this open access version If you believe that this document breaches copyright please contact us providing details and we will investigate your claim. Please direct all enquiries to [email protected] Download date: 30. Sep. 2021 Clinical Therapeutics/Volume 43, Number 1, 2021 Reduced Mortality After Oral Polio Vaccination and Increased Mortality After Diphtheria-tetanus-pertussis Vaccination in Children in a Low-income Setting Christian Bjerregård Øland, MSc1;Søren Wengel Mogensen, MSc1,2; Amabelia Rodrigues, PhD1; Christine S. Benn, DMSc3,4; and Peter Aaby, DMSc1,3 1Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau; 2Department of Math- ematical Sciences, University of Copenhagen, Copenhagen, Denmark; 3Research Centre for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; and 4OPEN, Institute of Clinical Research, University of Southern Denmark/ Odense University Hospital, Odense, Denmark ABSTRACT MV is given, DTP-vaccinated and MV-unvaccinated children had higher mortality (HR ¼ 2.76; 95% CI, Purpose: The diphtheria-tetanus-pertussis vaccine 1.36e5.59) than children who had received MV after (DTP) and oral polio vaccine (OPV) were introduced DTP, and among children who received DTP with in children 3 of 5 months of age in 1981e1983 in MV or after MV, DTP-only vaccination was Bandim, in the capital of Guinea-Bissau. Because DTP associated with a higher mortality than DTP with has been linked to deleterious nonspecific effects OPV (HR ¼ 6.25; 95% CI, 2.55e15.37). (NSEs) and OPV to beneficial NSEs, we followed up Implications: Because the 2 vaccines had differential this cohort to 3 years of age and examined the effects effects and the healthiest children were vaccinated first, of DTP with OPV on all-cause mortality and the selection biases are unlikely to explain the estimated interactions of DTP and OPV with the measles impact on child survival. OPV had beneficial NSEs, and vaccine (MV). administration of OPV with DTP may have reduced the Methods: DTP and OPV were offered at 3 monthly negative effects of DTP. (Clin Ther. 2021;43:172e184) community weighing sessions. Vaccination groups 2020 The Author(s). Published by Elsevier Inc. This were defined by the last vaccine received. We © is an open access article under the CC BY-NC-ND license compared overall mortality for different groups in (http://creativecommons.org/licenses/by-nc-nd/4.0/). Cox proportional hazards regression models, Key words: child mortality, diphtheria-tetanus- reporting hazards ratios (HRs) with 95% CIs. pertussis vaccine, DTP, measles vaccine, non-specific Findings: The study cohort included 1491 children effects of vaccines, oral polio vaccine. born in Bandim from December 1980 to December 1983. From 3 to 35 months of age, with censoring for MV, children vaccinated with DTP and/or OPV had higher mortality than both unvaccinated children INTRODUCTION ¼ e (HR l.66; 95% CI, 1.03 2.69) and OPV-only The effect of vaccines on overall survival had not been ¼ vaccinated children (HR 2.81; 95% CI, assessed in randomized clinical trials (RCTs) when the e 1.02 7.69); DTP-only vaccinated children had higher Expanded Program on Immunization was initiated in mortality than OPV-only vaccinated children (HR ¼ 3.38; 95% CI, 1.15-e9.93). In the age group of 3e8 months, before MV is administered, DTP- Accepted for publication November 11, 2020 https://doi.org/10.1016/j.clinthera.2020.11.010 only vaccination was associated with a higher 0149-2918/$ - see front matter mortality than DTP with OPV (HR ¼ 3.38; 95% CI, © 2020 The Author(s). Published by Elsevier Inc. This is an open access 1.59e7.20). Between 9 and 35 months of age, when article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). 172 Volume 43 Number 1 C.B. Øland et al. 1974. The disease-protective effects were known; effects METHODS on survival were assumed to be proportional to the Demographic Surveillance burden of infection. Hence, the main interest was at Bandim Health Project (BHP) was started in 1978 in which age to vaccinate.1 However, subsequent studies an urban district. In 1978e1979, mortality among e of the introduction of measles vaccine (MV)2 6 children younger than 5 years was nearly 500 per suggested that the MV had beneficial nonspecific effects 1000.17 Malnutrition was assumed to be the main (NSEs) on child survival (ie, effects on survival not cause; BHP was initiated to determine why children explained by prevention of the vaccine-targeted disease).7 were malnourished.18 However, severe malnutrition The World Health Organization (WHO) recently was not evident, and to understand the high mortality, sponsored a review of the potential NSEs of the BCG we started population follow-up. Four health workers vaccine, diphtheria-tetanus-pertussis vaccine (DTP), identified pregnant women, encouraged women to and MV8,9 for child mortality in low-income countries. attend antenatal clinics, and followed up children BCG and MV had beneficial NSEs. The point estimate younger than 3 years with anthropometric for DTP was in the opposite direction.8 Although measurements. Each health care worker supervised 2 protective against the 3 target diseases, DTP apparently subdistricts; they kept lists of pregnant women and e increased susceptibility to unrelated infections.10 13 children younger than 3 years. BHP had no Other nonlive vaccines may also be associated with computerized registration system until 1990 but kept increased mortality.14,15 OPV was not examined. an A5 BHP card with weights and vaccination dates There are surprisingly few studies of OPV and DTP for each child. Growth cards were kept by the mother. and child survival in the medical literature. We have The study of nutritional status was planned by the data from 40 years ago when OPV and DTP were Swedish Agency for Research Collaboration and the introduced in Guinea-Bissau in the 1980s. Few sites Ministry of Health in Guinea-Bissau.16 have similar data, so we have gone back to examine the natural experiment of introducing DTP and OPV. Anthropometry In an urban area, weighing sessions were organized The health care workers arranged 3 monthly every 3 months to identify malnourished children. weighing sessions in each subdistrict. Mothers were When vaccines became available in June 1981, OPV notified before a community weighing. The following and DTP were offered from 3 months of age in morning, the child's weight was measured and noted connection with the weighing sessions. on the BHP card. Inadvertently, this created a natural experiment among 3- to 5-month-old children; some received Vaccinations vaccines when just 3 months old, whereas others were BHP organized MV campaigns in December 1979 3,19 nearly 6 months old before they were vaccinated. and December 1980. In June 1981, BHP started Thus, allocation was determined by birthdays and the to provide vaccines at the weighing sessions. A nurse dates of weighing sessions and not by selection biases. from the health center followed the weighing team In this natural experiment, DTP-vaccinated children and vaccinated eligible children. DTP and OPV were had higher mortality than children not yet vaccinated provided to children from 3 months of age and MV with DTP from 3 to 5 months of age.16 to children from 9 months of age. OPV was not We examine the effects of OPV and DTP up to 3 given at birth. Doses of DTP and OPV could be years of age in the same cohort.16 After 6 months of given with 1-month intervals, but because we only age, the unvaccinated group was increasingly arranged quarterly weighing sessions, most children composed of children who had not been vaccinated had longer intervals. In several periods, either OPV 16 because they were frail or malnourished or had or DTP was missing. BCG was rarely provided traveled to rural areas. Because most children were because nurses were not trained to administer subsequently vaccinated with MV, we also examined intradermal vaccinations. possible interactions between DTP and OPV with An expatriate nurse of the supervising field staff MV. Because there are plans to stop OPV globally in sometimes organized catch-up vaccination sessions 2024, we have particularly tried to assess the NSEs without weighing, but vaccinations were noted on of OPV on child survival. BHP cards. Both nurses and mothers thought that January 2021 173 Clinical Therapeutics sick children should not be vaccinated; BHP cards Study Cohort often indicated that the child was sick, malnourished, We included children born December 3, 1980, to or orphan to explain why an eligible child had not December 31, 1983.
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