A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain

Vaccine

Volumn 32, Issue 47, 2014, Pages 6220-6226

  Juan Giner, Aitana ^a   Domicent, Camille ^b   Langendorf, Céline ^a   Roper, Martha H ^c   Baoundoh, Paul ^d   Fermon, Florence ^d   Gakima, Primitive ^d   Zipursky, Simona ^e   Tamadji, Mbaihol ^f   Grais, Rebecca F ^a  

^a EPICENTRE   (France)

^b Institut Scientifique de Sante Publique   (Belgium)

^c Médecins Sans Frontières ^*  (United States)

^d MÉDECINS SANS FRONTIÈRES   (Switzerland)

^e WORLD HEALTH ORGANIZATION   (Switzerland)

^f Ministry of Public Health   (Chad)

Author keywords

Cold chain; Controlled temperature chain; Immunogenicity; Maternal and neonatal tetanus elimination; Tetanus toxoid

Indexed keywords

IMMUNOGLOBULIN G; TETANUS ANTIBODY; TETANUS TOXOID; BACTERIUM ANTIBODY; VACCINE;

ADOLESCENT; ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; CHAD; COLD CHAIN; CONTROLLED STUDY; CONTROLLED TEMPERATURE CHAIN; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; ENVIRONMENTAL TEMPERATURE; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FEVER; HUMAN; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SINGLE BLIND PROCEDURE; STANDARD; TETANUS; VACCINATION; BLOOD; FREEZING; IMMUNOLOGY; MIDDLE AGED; PROCEDURES; TEMPERATURE; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, BACTERIAL; CHAD; DRUG STORAGE; FEMALE; HUMANS; IMMUNOGLOBULIN G; MIDDLE AGED; REFRIGERATION; SINGLE-BLIND METHOD; TEMPERATURE; TETANUS; TETANUS TOXOID; VACCINE POTENCY; YOUNG ADULT;

EID: 84907983236     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.09.027     Document Type: Article

References (32)

1. Humphreys G. Vaccination: rattling the supply chain. Bull World Health Organ 2011, 89(5):324-325.
2. Zaffran M., Vandelaer J., Kristensen D., et al. The imperative for stronger vaccine supply and logistics systems. Vaccine 2013, 31(Suppl 2):B73-B80.
3. Halm A., Yalcouyé I., Kamissoko M., et al. Using oral polio vaccine beyond the cold chain: a feasibility study conducted during the national immunization campaign in Mali. Vaccine 2010, 28(19):3467-3472.
4. Hipgrave D.B., Tran T.N., Huong V.M., et al. Immunogenicity of a locally produced hepatitis B vaccine with the birth dose stored outside the cold chain in rural Vietnam. Am J Trop Med Hyg 2006, 74(2):255-260.
5. Kerdpanich A., Chokephaibulkit K., Watanaveeradej V., et al. Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37°C for seven days. Hum Vaccine 2011, 7(1):74-80.
6. Otto B.F., Suarnawa I.M., Stewart T., et al. At-birth immunisation against hepatitis B using a novel pre-filled immunisation device stored outside the cold chain. Vaccine 1999, 18(5-6):498-502.
7. Quiroga R., Halkyer P., Gil F., Nelson C., Kristensen D. A prefilled injection device for outreach tetanus immunization by Bolivian traditional birth attendants. Rev Panam Salud Publica 1998, 4(1):20-25.
8. Ren Q., Xiong H., Li Y., Xu R., Zhu C. Evaluation of an outside-the-cold-chain vaccine delivery strategy in remote regions of western China. Public Health Rep 2009, 124(5):745-750.
9. Sutanto A., Suarnawa I.M., Nelson C.M., Stewart T., Soewarso T.I. Home delivery of heat-stable vaccines in Indonesia: outreach immunization with a prefilled, single-use injection device. Bull World Health Organ 1999, 77(2):119-126.
10. Wang L., Li J., Chen H., et al. Hepatitis B vaccination of newborn infants in rural China: evaluation of a village-based, out-of-cold-chain delivery strategy. Bull World Health Organ 2007, 85(9):688-694.
11. Zipursky S., Boualam L., Cheikh D.O., et al. Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad. Vaccine 2011, 29(34):5652-5656.
12. McCarney S., Zaffran M. Controlled temperature chain. The new term for out of the cold chain 2009, PATH, Ferney.
13. WHO Temperature sensitivity of vaccines. WHO/IVB/06.10 2006, WHO, Geneva.
14. WHO Making use of vaccine vial monitors flexible vaccine management for polio. WHO/V&B/00.14 2000, WHO, Geneva.
15. WHO Vaccine vial monitor. PQS performance specification. WHO/PQS/E06/IN05.1 2006, WHO, Geneva.
16. WHO-UNICEF-UNFPA Achieving and sustaining maternal and neonatal tetanus elimination. Strategic plan 2012-2015 2012, WHO-UNICEF-UNFPA, Geneva.
17. WHO Maternal and neonatal tetanus (MNT) elimination. Progress towards global MNT elimination 2012, WHO, Geneva, Available at 〈http://www.who.int/immunization/diseases/MNTE_initiative/en/index4.html〉.
18. WHO Requirements for diphtheria, tetanus, pertussis and combined vaccines. Annex 2. Technical report series no. 800 1990, WHO, Geneva.
19. WHO Production and control of tetanus vaccine. A training curriculum. Module IV. Microbiological and immunochemical tests. WHO/VSQ/GEN/94.5 1994, WHO, Geneva.
20. WHO Recommendations to assure the quality, safety and efficacy of tetanus vaccines. Replacement of: TRS 800, Annex 2 and TRS 927, Annex 5 2012, WHO, Geneva.
21. UNICEF Designing the questionnaire. Monitoring progress toward the goals of the world summit for children. A practical handbook for multiple-indicator surveys 1995, UNICEF, (Chapter 3).
22. Borrow R., Balmer P., Roper M. The immunological basis for immunization series Module 3: tetanus update 2006 2007, WHO Department of Immunization, Vaccines and Biologicals, Geneva.
23. Simonsen O., Schou C.H.I. Modification of the ELISA for the estimation of tetanus antitoxin in human sera. J Biol Stand 1987, 15:143-157.
24. Dokmetjian J., Della Valle C., Lavigne V., de Luján C.M., Manghi M.a. A possible explanation for the discrepancy between ELISA and neutralising antibodies to tetanus toxin. Vaccine 2000, 18(24):2698-2703.
25. Schöndorf I., Banzhoff A., Nicolay U., Diaz-Mitoma F. Overcoming the need for a cold chain with conjugated meningococcal group C vaccine: a controlled, randomized, double-blind study in toddlers on the safety and immunogenicity of Menjugate, stored at room temperature for 6 months. Vaccine 2007, 25(7):1175-1182.
26. WHO Tetanus vaccine. WHO position paper. Wkly Epidemiol Rec Relev 2006, 81(20):198-208.
27. WHO Vaccine preventable diseases: monitoring system July 2014 global summary 2014, WHO, Geneva, Available at 〈http://apps.who.int/immunization_monitoring/globalsummary〉.
28. Lloyd J.C., Haber P., Mootrey G.T., Braun M.M., Rhodes P.H., Chen R.T. Adverse event reporting rates following tetanus-diphtheria and tetanus toxoid vaccinations: data from the vaccine adverse event reporting system (VAERS), 1991-1997. Vaccine 2003, 21(25-26):3746-3750.
29. Deming M.S., Roungou J-B., Kristiansen M., et al. Tetanus toxoid coverage as an indicator of serological protection against neonatal tetanus. Bull World Health Organ 2002, 80(9):696-703.
30. Kurtzhals J.A.L., Kjeldsen K., Hey A.S., O-odera E.A.O. Immunity to tetanus and diphtheria in rural Africa. Am J Trop Med Hyg 1997, 56(5):576-579.
31. Kshirsagar N., Mur N., Thatte U., et al. Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults. Vaccine 2007, 25(Suppl 1):A101-A107.
32. Lydon P., Zipursky S., Tevi-Benissan C., et al. Economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of meningitis A vaccine in Chad. Bull World Health Organ 2014, 92(2):86-92.