Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial

Sodiomon B Sirima, Alphonse Ouedraogo, Nouhoun Barry, Mohamadou Siribie, Alfred Tiono, Issa Nébié, Amadou Konaté, Gloria Damoaliga Berges, Amidou Diarra, Moussa Ouedraogo, Edith C Bougouma, Issiaka Soulama, Alimatou Hema, Shrimati Datta, Yuanyuan Liang, Elizabeth T Rotrosen, J Kathleen Tracy, Leslie P Jamka, Jennifer J Oshinsky, Marcela F Pasetti, Kathleen M Neuzil, Matthew B Laurens, Sodiomon B Sirima, Alphonse Ouedraogo, Nouhoun Barry, Mohamadou Siribie, Alfred Tiono, Issa Nébié, Amadou Konaté, Gloria Damoaliga Berges, Amidou Diarra, Moussa Ouedraogo, Edith C Bougouma, Issiaka Soulama, Alimatou Hema, Shrimati Datta, Yuanyuan Liang, Elizabeth T Rotrosen, J Kathleen Tracy, Leslie P Jamka, Jennifer J Oshinsky, Marcela F Pasetti, Kathleen M Neuzil, Matthew B Laurens

Abstract

Objectives: In 2017, the World Health Organisation (WHO) pre-qualified a single-dose typhoid conjugate vaccine (TCV) and identified TCV co-administration studies as a research priority. Accordingly, we tested co-administration of Typbar TCV® (Bharat Biotech International) with measles-rubella (MR) and yellow fever (YF) vaccines.

Methods: We conducted a randomized, double-blind, and controlled, phase 2 trial in Ouagadougou, Burkina Faso. Healthy children aged 9-11 months were randomized 1:1 to receive TCV (Group 1) or control vaccine (inactivated polio vaccine (IPV), Group 2). Vaccines were administered intramuscularly with routine MR and YF vaccines. Safety was assessed by (1) local and systemic reactions on days 0, 3, and 7; (2) unsolicited adverse events within 28 days; and (3) serious adverse events (SAEs) within six months after immunization.

Results: We enrolled, randomized, and vaccinated 100 eligible children (49 Group 1 and 51 Group 2). Safety outcomes occurred with similar frequency in both groups: local/solicited reactions (Group 1: 1/49, Group 2: 3/50), systemic/solicited reactions (Group 1: 4/49, Group 2: 9/50), unsolicited adverse events (Group 1: 26/49, Group 2: 33/51), and SAEs (Group 1: 2/49, Group 2: 3/51). TCV conferred robust immunogenicity without interference with MR or YF vaccines.

Conclusion: TCV can be safely co-administered with MR and YF vaccines to children at the 9-month vaccination visit.

Keywords: Burkina Faso; Coadministration; Typhoid conjugate vaccine; Typhoid fever; Yellow fever vaccine.

Conflict of interest statement

Declaration of Competing Interest The authors report no declarations of interest.

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Figures

Figure 1
Figure 1
Disposition of participants (CONSORT flow diagram).
Figure 2
Figure 2
(A) Anti-Vi IgG antibody titers before vaccination (day 0) and 28 days after vaccination. (B) Anti-yellow fever neutralizing antibody titers before vaccination (day 0) and 28 days after vaccination. (C) Anti-measles titers before vaccination (day 0) and 28 days after vaccination. (D) Anti-rubella antibody titers before vaccination (day 0) and 28 days after vaccination. (E) Anti-tetanus IgG antibody titers before vaccination (day 0) and 28 days after vaccination.

References

    1. Alberer M., Burchard G., Jelinek T., Reisinger E., Beran J., Hlavata L.C. Safety and immunogenicity of typhoid fever and yellow fever vaccines when administered concomitantly with quadrivalent meningococcal ACWY glycoconjugate vaccine in healthy adults. J Travel Med. 2015;22(1):48–56.
    1. Capeding M.R., Alberto E., Feser J., Mooney J., Tang Y., Audet S.A. Immunogenicity and safety of concurrent or sequential administration of live, attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) and measles-mumps-rubella vaccine in infants 9-12 months of age in the Philippines: a non-inferiority phase 4 randomized clinical trial. Vaccine X. 2020;6
    1. Dimonte S., Bruske E.I., Hass J., Supan C., Salazar C.L., Held J. Sporozoite route of infection influences in vitro var gene transcription of Plasmodium falciparum parasites from controlled human infections. J Infect Dis. 2016;214(6):884–894.
    1. Diseases G.B.D., Injuries C. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–1222.
    1. GBD 2019 Diseases and Injuries Collaborators Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–1222.
    1. Gotuzzo E., Yactayo S., Cordova E. Efficacy and duration of immunity after yellow fever vaccination: systematic review on the need for a booster every 10 years. Am J Trop Med Hyg. 2013;89(3):434–444.
    1. Haidara F.C., Tapia M.D., Sow S.O., Doumbia M., Coulibaly F., Diallo F. Evaluation of a booster dose of pentavalent rotavirus vaccine coadministered with measles, yellow fever, and meningitis A vaccines in 9-month-old Malian infants. J Infect Dis. 2018;218(4):606–613.
    1. Hoest C., Seidman J.C., Lee G., Platts-Mills J.A., Ali A., Olortegui M.P. Vaccine coverage and adherence to EPI schedules in eight resource poor settings in the MAL-ED cohort study. Vaccine. 2017;35(3):443–451.
    1. Institute for Health Metrics and Evaluation . 2020. Global burden of disease, typhoid fever — level 4 cause.
    1. Jin C., Gibani M.M., Moore M., Juel H.B., Jones E., Meiring J. Efficacy and immunogenicity of a Vi-tetanus toxoid conjugate vaccine in the prevention of typhoid fever using a controlled human infection model of Salmonella Typhi: a randomised controlled, phase 2b trial. Lancet. 2017;390(10111):2472–2480.
    1. Kundu R., Kandulna A.K., Nayak U., Jangid S.K., Babu T.R., Vukkala R. Immunogenicity and safety of typhoid conjugate vaccine in healthy Indian subjects: a randomized, active-controlled, comparative clinical trial. Indian Pediatr. 2020;57(7):625–630.
    1. Laurens M.B., Sirima S.B., Rotrosen E.T., Siribie M., Tiono A., Ouedraogo A. A phase II, randomized, double-blind, controlled safety and immunogenicity trial of typhoid conjugate vaccine in children under 2 years of age in Ouagadougou, Burkina Faso: a methods paper. Clin Infect Dis. 2019;68(Suppl. 2):S59–S66.
    1. Ma S.J., Li X., Xiong Y.Q., Yao A.L., Chen Q. Combination measles-mumps-rubella-varicella vaccine in healthy children: a systematic review and meta-analysis of immunogenicity and safety. Medicine (Baltimore) 2015;94(44):e1721.
    1. Marks F., von Kalckreuth V., Aaby P., Adu-Sarkodie Y., El Tayeb M.A., Ali M. Incidence of invasive salmonella disease in sub-Saharan Africa: a multicentre population-based surveillance study. Lancet Glob Health. 2017;5(3):e310–e323.
    1. Mattiuzzo G., Knezevic I., Hassall M., Ashall J., Myhill S., Faulkner V. Harmonization of Zika neutralization assays by using the WHO International Standard for anti-Zika virus antibody. NPJ Vaccin. 2019;4:42.
    1. Milligan R., Paul M., Richardson M., Neuberger A. Vaccines for preventing typhoid fever. Cochrane Database Syst Rev. 2018;5
    1. Mohan V.K., Varanasi V., Singh A., Pasetti M.F., Levine M.M., Venkatesan R. Safety and immunogenicity of a Vi polysaccharide-tetanus toxoid conjugate vaccine (Typbar-TCV) in healthy infants, children, and adults in typhoid endemic areas: a multicenter, 2-cohort, open-label, double-blind, randomized controlled phase 3 study. Clin Infect Dis. 2015;61(3):393–402.
    1. Qamar F.N., Yousafzai M.T., Khaliq A., Karim S., Memon H., Junejo A. Adverse events following immunization with typhoid conjugate vaccine in an outbreak setting in Hyderabad, Pakistan. Vaccine. 2020;38(19):3518–3523.
    1. SAGE Working Group on Typhoid Vaccines & the WHO Secretariat . 2017. Background paper to SAGE on typhoid vaccine policy recommendations.
    1. Shakya M., Colin-Jones R., Theiss-Nyland K., Voysey M., Pant D., Smith N. Phase 3 efficacy analysis of a typhoid conjugate vaccine trial in Nepal. N Engl J Med. 2019;381(23):2209–2218.
    1. Simon J.K., Maciel M., Jr., Weld E.D., Wahid R., Pasetti M.F., Picking W.L. Antigen-specific IgA B memory cell responses to Shigella antigens elicited in volunteers immunized with live attenuated Shigella flexneri 2a oral vaccine candidates. Clin Immunol. 2011;139(2):185–192.
    1. Sirima S.B., Ouedraogo A., Barry N., Siribie M., Tiono A.B., Nébié I. Safety and immunogenicity of co-administration of meningococcal type A and measles rubella vaccines with typhoid conjugate vaccine in children aged 15–23 months in Burkina Faso. Int J Infect Dis. 2020
    1. Tapia M.D., Sow S.O., Medina-Moreno S., Lim Y., Pasetti M.F., Kotloff K. A serosurvey to identify the window of vulnerability to wild-type measles among infants in rural Mali. Am J Trop Med Hyg. 2005;73(1):26–31.
    1. Wong V.K., Baker S., Pickard D.J., Parkhill J., Page A.J., Feasey N.A. Phylogeographical analysis of the dominant multidrug-resistant H58 clade of Salmonella Typhi identifies inter- and intracontinental transmission events. Nat Genet. 2015;47(6):632–639.
    1. World Health Organization Typhoid vaccines: WHO position paper, March 2018 — recommendations. Vaccine. 2019;37(2):214–216.
    1. World Health Organization . 2019. Measles — global situation.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner