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NISH (NITAG Support Hub) 12: Whole-cell (wP) Hexavalent vaccine: Google Scholar and other Grey Literature

This Library Guide is a collection of useful documents & evidence on the safety, efficacy, effectiveness and impact of the whole-cell (wP) Hexavalent vaccine to support NITAG members and other policy makers throughout Africa with making evidence-based r

Google Scholar and other Grey Literature

Bandyopadhyay, A. S., Gast, C., Rivera, L., Sáez-Llorens, X., Oberste, M. S., Weldon, W. C., Modlin, J., Clemens, R., Clemens, S. A. C., & Jimeno, J. (2021). Safety and immunogenicity of inactivated poliovirus vaccine schedules for the post-eradication era: A randomised open-label, multicentre, phase 3, non-inferiority trial. The Lancet Infectious Diseases, 21(4), 559–568.https://www.thelancet.com/action/showPdf?pii=S1473-3099%2820%2930555-7

Chacon, G. P., Estcourt, M. J., Totterdell, J., Campbell, D. E., Perrett, K. P., Marsh, J. A., ... & Snelling, T. L. (2020). OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule. BMJ open10(12), e042838.https://bmjopen.bmj.com/content/bmjopen/10/12/e042838.full.pdf

Chitkara, A. J., Ferrer, M. P., Forsyth, K., Guiso, N., Heininger, U., Hozbor, D. F., ... & von König, C. W. (2020). Pertussis vaccination in mixed markets: Recommendations from the Global Pertussis Initiative. International Journal of Infectious Diseases96, 482-488.https://doi.org/10.1016/j.ijid.2020.04.081

Choy, R. K., Bourgeois, A. L., Ockenhouse, C. F., Walker, R. I., Sheets, R. L., & Flores, J. (2022). Controlled human infection models to accelerate vaccine development. Clinical Microbiology Reviews, 35(3), e00008-21.

Dolhain, J., Janssens, W., Sohn, W. Y., Dindore, V., & Mukherjee, P. (2019). Integration of hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine within existing national recommendations following a birth dose of monovalent hepatitis B virus vaccine: results of a systematic review in the Asia Pacific region. Expert Review of Vaccines18(9), 921-933. https://doi.org/10.1080/14760584.2019.1646643

Donato, C., Cowley, D., & Kirkwood, C. (2016). 10 Rotavirus. Foodborne Viral Pathogens, 179.

Gregori, L. M. (n.d.). Troubles neuropsychiatriques associés aux vaccins.

Halperin, S. A., Tapiero, B., Diaz-Mitoma, F., Law, B. J., Hoffenbach, A., Zappacosta, P. S., Radley, D., McCarson, B. J., Martin, J. C., & Brackett, L. E. (2009). Safety and immunogenicity of a hexavalent diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae b conjugate–hepatitis B vaccine at 2, 3, 4, and 12–14 months of age. Vaccine, 27(19), 2540–2547. https://doi.org/10.1016/j.vaccine.2008.11.115

Hayman, B., & Pagliusi, S. (2020). Emerging vaccine manufacturers are innovating for the next decade. Vaccine: X, 5, 100066.

Heininger, U., The, D.-H., Sänger, R., Jacquet, J.-M., & Schuerman, L. (2007). Booster immunization with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate combination vaccine in the second year of life: Safety, immunogenicity and persistence of antibody responses. Vaccine, 25(6), 1055–1063.https://doi.org/10.1016/j.vaccine.2006.09.060

Koen, A., Madhi, S., Lyabis, O., Vidor, E., Cowper, B., Marais, T., ... & Vigne, C. (2021). Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa. Human Vaccines & Immunotherapeutics17(6), 1770-1778.https://doi.org/10.1080/21645515.2020.1839289

Kumar, P., Hamana, A., Bird, C., Dotson, B., Saleh-Birdjandi, S., Volkin, D. B., & Joshi, S. B. (2024). Evaluating the Compatibility of Three Aluminum Salt-Adjuvanted Recombinant Protein Antigens (Trivalent NRRV) Combined with a Mock Trivalent Sabin-IPV Vaccine: Analytical and Formulation Challenges. Vaccines, 12(10), 1102.https://doi.org/10.3390/vaccines12101102

Kumar, P., Bird, C., Holland, D., Joshi, S. B., & Volkin, D. B. (2022). Current and next-generation formulation strategies for inactivated polio vaccines to lower costs, increase coverage, and facilitate polio eradication. Human Vaccines & Immunotherapeutics18(7), 2154100.https://www.tandfonline.com/doi/abs/10.1080/21645515.2022.2154100%4010.1080/tfocoll.2022.0.issue-Vaccine-Logisticshttps://www.tandfonline.com/

le Dr Richard Moskowitz, M. (n.d.). Médecin depuis plus de 50 ans, il déclare: L’hystérie actuelle au sujet de la rougeole ne repose nullement sur la science!

Le vaccin contre l’hépatite, B. (n.d.). À lire AVANT de voter la loi sur l’extension de l’obligation vaccinale!!

Madhi, S. A., Mitha, I., Cutland, C., Groome, M., & Santos-Lima, E. (2011). Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. The Pediatric Infectious Disease Journal30(4), e68-e74.DOI: 10.1097/INF.0b013e31820b93d2

Madhi, S. A., López, P., Zambrano, B., Jordanov, E., B’Chir, S., Noriega, F., & Feroldi, E. (2019). Antibody persistence in pre-school children after hexavalent vaccine infant primary and booster administration. Human vaccines & immunotherapeutics15(3), 658-668.https://doi.org/10.1080/21645515.2018.1546524

Madhi, S. A., Koen, A., Cutland, C., Groome, M., & Santos-Lima, E. (2013). Antibody persistence and booster vaccination of a fully liquid hexavalent vaccine coadministered with measles/mumps/rubella and varicella vaccines at 15–18 months of age in healthy South African infants. The Pediatric Infectious Disease Journal32(8), 889-897.

Mahmoud, A. (2011). A global road map is needed for vaccine research, development, and deployment. Health Affairs, 30(6), 1034–1041.

Mallet, E., Belohradsky, B. H., Lagos, R., Gothefors, L., Camier, P., Carrière, J.-P., Kanra, G., Hoffenbach, A., Langue, J., & Undreiner, F. (2004). A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety. Vaccine, 22(11–12), 1343–1357.https://doi.org/10.1016/j.vaccine.2003.09.039

Mangarule, S., Prashanth, S., Kawade, A., Ravi, M., Padmavathi, I., Palkar, S., Tripathi, V., Singh, R., Maurya, M., & Mitra, M. (2022). Lot-to-lot consistency of a hexavalent DTwP-IPV-HB-PRP∼ T vaccine and non-inferiority to separate DTwP-HB-PRP∼ T and IPV antigen-matching vaccines at 6–8, 10–12, and 14–16 weeks of age co-administered with oral rotavirus vaccine in healthy infants in India: A multi-center, randomized, controlled study. Vaccine: X, 12, 100216. https://doi.org/10.1016/j.jvacx.2022.100216

Mangarule, S., Palkar, S., Mitra, M., Ravi, M. D., Singh, R., Moureau, A., ... & Noriega, F. (2022). Antibody persistence following administration of a hexavalent DTwP-IPV-HB-PRP∼ T vaccine versus separate DTwP-HB-PRP∼ T and IPV vaccines at 12–24 months of age and safety and immunogenicity of a booster dose of DTwP-IPV-HB-PRP∼ T in healthy infants in India. Vaccine: X11, 100190.https://doi.org/10.1016/j.jvacx.2022.100190

Mangarule, S., Palkar, S., Mitra, M., Ravi, M. D., Dubey, A. P., Moureau, A., ... & Noriega, F. (2022). Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼ T vaccine versus separate DTwP-HB-PRP∼ T and IPV vaccines in healthy infants in India. Vaccine: X10, 100137.https://doi.org/10.1016/j.jvacx.2021.100137

Mohanty, L., Sharma, S., Behera, B., Panwar, S., Paliwal, C., Gupta, A., ... & Singh, A. (2018). A randomized, open label trial to evaluate and compare the immunogenicity and safety of a novel liquid hexavalent DTwP-Hib/Hep B-IPV (EasySix™) to licensed combination vaccines in healthy infants. Vaccine36(17), 2378-2384.https://doi.org/10.1016/j.vaccine.2017.09.029

Mojgani, N. (2014). Immunogenicity and Efficacy of Different Haemophilus influenzae type b Vaccines. Archives of Razi Institute, 69(2), 115–125. 10.7508/ari.2014.02.001

Nunes, M. C., & Madhi, S. A. (2013). Review of a new fully liquid, hexavalent vaccine: HexaximExpert opinion on biological therapy13(4), 575–593. https://doi.org/10.1517/14712598.2013.774368 DOI: 10.1517/14712598.2013.774368

Orsi, A., Azzari, C., Bozzola, E., Chiamenti, G., Chirico, G., Esposito, S., Francia, F., Lopalco, P., Prato, R., Russo, R., Villani, A., & Franco, E. (2018). Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts. Journal of preventive medicine and hygiene59(2), E107–E119. https://pmc.ncbi.nlm.nih.gov/articles/PMC6069402/pdf/jpmh-2018-02-e107.pdf

Ozgenç, M. (n.d.). TURQUIE: Plus de 10.000 familles rejettent les vaccinations pour leurs enfants.

Patterson, J., Kagina, B. M., Gold, M., Hussey, G. D., & Muloiwa, R. (2017). Adverse events following primary and secondary immunisation with whole-cell pertussis: a systematic review protocol. BMJ open7(1), e012945.https://bmjopen.bmj.com/content/bmjopen/7/1/e012945.full.pdf

Ray, S., & Pemde, H. K. (2020). DIPHTHERIA, PERTUSSIS, TETANUS VACCINES. Indian Journal of Practical Pediatrics22(4), 367.https://iapindia.org/pdf/ijpp/Vol-22-No-4-VACCINOLOGY-I.pdf#page=7

Sanchez, L., Rungmaitree, S., Kosalaraksa, P., Jantarabenjakul, W., Leclercq, J., Yaiprayoon, Y., Midde, V. J., Varghese, K., Mangarule, S., & Noriega, F. (2023). Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~ T Vaccine Versus Separate DTwP-HB-PRP~ T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand. The Pediatric Infectious Disease Journal, 42(8), 711–718.  DOI: 10.1097/INF.0000000000003975

Sawant, N. (2021). Developability Assessments and Analytical Characterization of Recombinant Protein Antigens Formulated as Low-Cost, Multi-Dose, Aluminum-Adjuvanted Vaccines. University of Kansas. https://www.proquest.com/docview

Sharma, H., Lalwani, S., Parekh, S., Pujari, P., Shewale, S., Palkar, S., Hanumante, N., Gokhale, S., Ks, J., & Kumar, R. (2022). A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months. Human Vaccines & Immunotherapeutics, 18(6), 2146435.https://doi.org/10.1080/21645515.2022.2146435

Vashishtha, V. M. (2018). Immunogenicity and safety of a novel liquid hexavalent DTwP-Hib/Hep B-IPV vaccine to licensed combination vaccines in healthy infants. Indian Pediatr55, 444.https://www.indianpediatrics.net/may2018/may-444.htm

World Health Organization. (2022). Bacterial vaccines in clinical and preclinical development 2021: An overview and analysis.https://books.google.co.za/books

Zepp, F., Knuf, M., Heininger, U., Jahn, K., Collard, A., Habermehl, P., Schuerman, L., & Sänger, R. (2004). Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants. Vaccine, 22(17–18), 2226–2233.https://doi.org/10.1016/j.vaccine.2003.11.044