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Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine versus Oral Polio Vaccine Alone in Healthy Infants in China

Saturday, 27th of August 2016

Jnl of Pediatric Infectious Diseases Soc, Volume 5 Issue 3, Pp. 287-296.

Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine versus Oral Polio Vaccine Alone in Healthy Infants in China

1. 1.   Rong-Cheng Li1,a,
2. 2.   Chang-Gui Li2,a,
3. 3.   Hai-Bo Wang3,a,
4. 4.   Hui-Min Luo3,
5. 5.   Yan-Ping Li1,
6. 6.   Jian-Feng Wang2,
7. 7.   Zhi-Fang Ying2,
8. 8.   Wen-Zhou Yu3,
9. 9.   Jean Denis Shu4,

10. Ning Wen3 and

11. Emmanuel Vidor5

1. ¹Guangxi Center for Disease Prevention and Control, Nanning, China
2. ²National Institutes for Food and Drug Control (NIFDC), Beijing, China
3. ³Chinese Center for Disease Control and Prevention, Beijing, China
4. ⁴Sanofi Pasteur, Beijing, China
5. ⁵Sanofi Pasteur, Lyon, France
6. Corresponding Author:
   Emmanuel Vidor, MD, Global Medical Affairs, Sanofi Pasteur, 2 Avenue Pont Pasteur, Lyon 69367, France. E-mail: emmanuel.vidor{at}sanofipasteur.com.
7. ↵a R.-C.L, C.-G.L, and H-B.W. contributed equally to this work.

           Received October 20, 2014.

           Accepted March 13, 2015.

Abstract below; full text is at http://jpids.oxfordjournals.org/content/5/3/287.full.pdf+html

Background Two vaccination schedules where inactivated polio vaccine (IPV) was followed by oral polio vaccine (OPV) were compared to an OPV-only schedule.

Methods Healthy Chinese infants received a 3-dose primary series of IPV-OPV-OPV (Group A), IPV-IPV-OPV (Group B), or OPV-OPV-OPV (Group C) at 2, 3, and 4 months of age. At pre-Dose 1, 1-month, and 14-months post-Dose 3, polio 1, 2, and 3 antibody titers were assessed by virus-neutralizing antibody assay with Sabin or wild-type strains. Adverse events were monitored.

Results Anti-polio 1, 2, and 3 titers were ≥8 (1/dil) in >99% of participants, and Group A and Group B were noninferior to Group C at 1-month post-Dose 3 as assessed by Sabin strain-based assay (SSBA). In Group A 1-month post-Dose 3, there was no geometric mean antibody titers (GMT) differences for types 1 and 3; type 2 GMTs were ≈3-fold higher by wild-type strain-based assay (WTBA) versus SSBA. For Group B, GMTs were ≈1.7- and 3.6-fold higher for types 1 and 2 via WTBA, while type 3 GMTs were similar. For Group C, GMTs were ≈6.3- and 2-fold higher for types 1 and 3 with SSBA, and type 2 GMTs were similar. Antibodies persisted in >96.6% of participants. Adverse event incidence in each group was similar.

Conclusions A primary series of 1 or 2 IPV doses followed by 2 or 1 OPV doses was immunogenic and noninferior to an OPV-only arm. SSBA was better at detecting antibodies elicited by OPV with antibody titers correlated to the number of OPV doses (NCT01475539).