Immunogenicity and safety of one dose of diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (Repevax®) followed by two doses of diphtheria, tetanus and poliomyelitis vaccine (Revaxis®) in adults aged ≥ 40 years not receiving a diphtheria- and tetanus-containing vaccination in the last 20 years.
BACKGROUND
The immunogenicity and safety of one dose of Tdap-IPV (tetanus, diphtheria, acellular pertussis and inactivated poliomyelitis vaccine) and two doses of Td-IPV (tetanus, diphtheria and inactivated poliomyelitis vaccine) were assessed in adults who had not received a diphtheria- and tetanus-containing vaccine in the last 20 years.


METHODS
This open-label, multicentre study was conducted in adults aged ≥ 40 years with no diphtheria- and tetanus-containing vaccine in the last 20 years. Participants received one dose of Tdap-IPV followed by two doses of Td-IPV (0, 1, 6 month schedule). Primary immunogenicity objectives: to demonstrate acceptable seroprotection rates (percentage of participants with antibody titre above threshold) post-dose 3 for diphtheria (≥ 0.1IU/mL by seroneutralization assay [SNA]); tetanus (≥ 0.1IU/mL by enzyme-linked immunosorbent assay [ELISA]); and poliomyelitis (≥ 8 1/dil by SNA); and to evaluate the percentage of participants with an antibody concentration ≥ 5EU/mL (by ELISA) for pertussis antigens post-dose 1. Seroprotection rates were acceptable if the lower limit of the 95% confidence interval (CI) was >95%. Percentage of participants with basic clinical immunity against diphtheria (≥ 0.01IU/mL) was also assessed. Safety (adverse events [AEs] and serious AEs) was assessed after each dose.


RESULTS
Overall, 336 participants were included (mean age: 60.2 years). Post-dose 3 seroprotection rates were: diphtheria, 94.6% (CI 91.5-96.8); tetanus and poliomyelitis, 100% (CI: 98.8-100). Percentage of participants with an antibody titre ≥ 5EU/mL against pertussis antigens was ≥ 95.8% for all five pertussis components. Basic clinical immunity against diphtheria was achieved in 100% (CI: 98.8-100) of participants. AEs were reported more frequently following vaccination with Tdap-IPV (post-dose 1: 65.3%) than with Td-IPV (post-dose 2: 48.3%; post-dose 3: 50.3%).


CONCLUSIONS
This study highlights the benefits of using Tdap-IPV followed by two doses of Td-IPV in an adult population to achieve maximal protection against diphtheria, tetanus, poliomyelitis and pertussis simultaneously.
Hautzentrum Dülmen, Praxisklinik Doctor Bockhorst/Doctor Dominicus, Vollenstrasse 8, 48249 Dülmen, Germany. Electronic address: praxis@hautzentrum-duelmen.de.
Rolf
R
Dominicus
National Network of Clinical Investigation in Vaccinology (REIVAC), Institut National de la Santé et de la Recherche Médicale (INSERM), France; Centre d'Investigation Clinique (CIC), INSERM, CHRU Montpellier Hôpital Saint-Eloi 80, av. Augustin Fliche, 34295 Montpellier Cedex 5, France. Electronic address: f-galtier@chu-montpellier.fr.
Florence
F
Galtier
Sanofi Pasteur MSD, 162, avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: PRichard@spmsd.com.
Patrick
P
Richard
Sanofi Pasteur MSD, 162, avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: MBaudin@spmsd.com.
Martine
M
Baudin
D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004165:Diphtheria / Q000517:prevention & control*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage*; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage*; D013742:Tetanus / Q000517:prevention & control*; D017778:Vaccines, Combined / Q000008:administration & dosage; D015164:Vaccines, Inactivated / Q000008:administration & dosage; D014917:Whooping Cough / Q000517:prevention & control*
D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; C051021:DTPP vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; D015164:Vaccines, Inactivated
Boosters; Immunogenicity; Safety; Seroprotection; Td-IPV; Tdap-IPV