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Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial.
Clin Infect Dis. 2013 Oct; 57(7):952-62.CI

Abstract

BACKGROUND

The 13-valent pneumococcal conjugate vaccine (PCV13) was licensed to replace the 7-valent pneumococcal conjugate vaccine (PCV7) based on serological noninferiority criteria. To date no randomized PCV13 pediatric trial has included clinical endpoints.

METHODS

This randomized double-blind trial compared the impact of PCV13 versus PCV7 on nasopharyngeal (NP) colonization and immunogenicity. Healthy infants were randomized (1:1) to receive PCV7 or PCV13 at ages 2, 4, 6, and 12 months; NP swabs were collected at 2, 4, 6, 7, 12, 13, 18, and 24 months, and blood was drawn at 7 and 13 months. Rates of NP acquisition and prevalence, and serotype-specific immunoglobulin G (IgG) concentrations were assessed.

RESULTS

The per protocol analysis population included 881 PCV13 and 873 PCV7 recipients. PCV13 significantly reduced NP acquisition of the additional PCV13 serotypes 1, 6A, 7F, and 19A; the cross-reacting serotype 6C; and the common PCV7 serotype 19F. For serotype 3, and the other PCV7 serotypes, there were no significant differences between the vaccine groups. There were too few serotype 5 events to draw inference. The impact on prevalence at predefined time points was similar to that observed with NP acquisition. PCV13 elicited significantly higher IgG responses for PCV13 additional serotypes and serotype 19F, and similar or lower responses for 6/7 PCV7 serotypes.

CONCLUSIONS

PCV13 resulted in lower acquisition and prevalence of NP colonization than PCV7 did for 4 additional PCV13 serotypes, and serotypes 6C and 19F. It was comparable with PCV7 for all other common serotypes. These findings predict vaccine effectiveness through both direct and indirect protection.

CLINICAL TRIALS REGISTRATION

NCT00508742.

Authors+Show Affiliations

Pediatric Infectious Disease Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23804191

Citation

Dagan, Ron, et al. "Comparative Immunogenicity and Efficacy of 13-valent and 7-valent Pneumococcal Conjugate Vaccines in Reducing Nasopharyngeal Colonization: a Randomized Double-blind Trial." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 57, no. 7, 2013, pp. 952-62.
Dagan R, Patterson S, Juergens C, et al. Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. Clin Infect Dis. 2013;57(7):952-62.
Dagan, R., Patterson, S., Juergens, C., Greenberg, D., Givon-Lavi, N., Porat, N., Gurtman, A., Gruber, W. C., & Scott, D. A. (2013). Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 57(7), 952-62. https://doi.org/10.1093/cid/cit428
Dagan R, et al. Comparative Immunogenicity and Efficacy of 13-valent and 7-valent Pneumococcal Conjugate Vaccines in Reducing Nasopharyngeal Colonization: a Randomized Double-blind Trial. Clin Infect Dis. 2013;57(7):952-62. PubMed PMID: 23804191.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. AU - Dagan,Ron, AU - Patterson,Scott, AU - Juergens,Christine, AU - Greenberg,David, AU - Givon-Lavi,Noga, AU - Porat,Nurith, AU - Gurtman,Alejandra, AU - Gruber,William C, AU - Scott,Daniel A, Y1 - 2013/06/26/ PY - 2013/6/28/entrez PY - 2013/6/28/pubmed PY - 2014/6/18/medline KW - S. pneumoniae KW - immunogenicity KW - nasopharyngeal colonization KW - pneumococcal conjugate vaccine KW - serotype prevalence SP - 952 EP - 62 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 57 IS - 7 N2 - BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) was licensed to replace the 7-valent pneumococcal conjugate vaccine (PCV7) based on serological noninferiority criteria. To date no randomized PCV13 pediatric trial has included clinical endpoints. METHODS: This randomized double-blind trial compared the impact of PCV13 versus PCV7 on nasopharyngeal (NP) colonization and immunogenicity. Healthy infants were randomized (1:1) to receive PCV7 or PCV13 at ages 2, 4, 6, and 12 months; NP swabs were collected at 2, 4, 6, 7, 12, 13, 18, and 24 months, and blood was drawn at 7 and 13 months. Rates of NP acquisition and prevalence, and serotype-specific immunoglobulin G (IgG) concentrations were assessed. RESULTS: The per protocol analysis population included 881 PCV13 and 873 PCV7 recipients. PCV13 significantly reduced NP acquisition of the additional PCV13 serotypes 1, 6A, 7F, and 19A; the cross-reacting serotype 6C; and the common PCV7 serotype 19F. For serotype 3, and the other PCV7 serotypes, there were no significant differences between the vaccine groups. There were too few serotype 5 events to draw inference. The impact on prevalence at predefined time points was similar to that observed with NP acquisition. PCV13 elicited significantly higher IgG responses for PCV13 additional serotypes and serotype 19F, and similar or lower responses for 6/7 PCV7 serotypes. CONCLUSIONS: PCV13 resulted in lower acquisition and prevalence of NP colonization than PCV7 did for 4 additional PCV13 serotypes, and serotypes 6C and 19F. It was comparable with PCV7 for all other common serotypes. These findings predict vaccine effectiveness through both direct and indirect protection. CLINICAL TRIALS REGISTRATION: NCT00508742. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/23804191/Comparative_immunogenicity_and_efficacy_of_13_valent_and_7_valent_pneumococcal_conjugate_vaccines_in_reducing_nasopharyngeal_colonization:_a_randomized_double_blind_trial_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/cit428 DB - PRIME DP - Unbound Medicine ER -