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Efficacy, Safety and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Children

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Efficacy, Safety and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Children Pediatr Infect Dis J, 2000;19:187–95 Vol. 19, No. 3 Copyright © 2000 by Lippincott Williams & Wilkins, Inc. Printed in U.S.A. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children STEVEN BLACK, MD, HENRY SHINEFIELD, MD, BRUCE FIREMAN, MA, EDWIN LEWIS, MPH, PAULA RAY, MPH, JOHN R. HANSEN, BA, LAURA ELVIN, KATHY M. ENSOR, RN, JILL HACKELL, MD, GEORGE SIBER, MD, FRANK MALINOSKI, MD, PHD, DACE MADORE, PHD, IH CHANG, PHD, ROBERT KOHBERGER, PHD, WENDY WATSON, MD, ROBERT AUSTRIAN, MD, KATHY EDWARDS, MD AND THE NORTHERN CALIFORNIA KAISER PERMANENTE VACCINE STUDY CENTER GROUP* Objective. To determine the efficacy, safety and 17 of the 17 cases of invasive disease caused by immunogenicity of the heptavalent CRM197 vaccine serotype in fully vaccinated children and pneumococcal conjugate vaccine against inva- 5 of 5 of partially vaccinated cases occurred in sive disease caused by vaccine serotypes and to the control group for a vaccine efficacy of 100%. determine the effectiveness of this vaccine Blinded case ascertainment was continued until against clinical episodes of otitis media. April, 1999. As of that time 40 fully vaccinated Methods. The Wyeth Lederle Heptavalent cases of invasive disease caused by vaccine sero- CRM197 (PCV) was given to infants at 2, 4, 6 and type had been identified, all but 1 in controls for 12 to 15 months of age in a double blind trial; an efficacy of 97.4% (95% confidence interval, 82.7 37 868 children were randomly assigned 1:1 to to 99.9%), and 52 cases, all but 3 in controls in the receive either the pneumococcal conjugate vac- intent-to-treat analysis for an efficacy of 93.9% cine or meningococcus type C CRM197 conjugate. (95% confidence interval, 79.6 to 98.5%). There The primary study outcome was invasive disease was no evidence of any increase of disease caused by vaccine serotype. Other outcomes in- caused by nonvaccine serotypes. Efficacy for oti- cluded overall impact on invasive disease re- tis media against visits, episodes, frequent otitis gardless of serotype, effectiveness against clini- and ventilatory tube placement was 8.9, 7.0, 9.3 cal otitis media visits and episodes, impact and 20.1% with P < 0.04 for all. In the analysis of against frequent and severe otitis media and spontaneously draining ears, serotype-specific ventilatory tube placement. In addition the sero- effectiveness was 66.7%. type-specific efficacy against otitis media was Conclusion. This heptavalent pneumococcal estimated in an analysis of spontaneously drain- conjugate appears to be highly effective in pre- ing ears. venting invasive disease in young children and Results. In the interim analysis in August, 1998, to have a significant impact on otitis media. INTRODUCTION Accepted for publication Dec. 20, 1999. Although the pneumococcus was first isolated more From the Kaiser Permanente Vaccine Study Center, Oakland, CA (SB, HS, BF, EL, PR, JRH, LE, KME); Wyeth Lederle than 100 years ago and the first pneumococcal vaccine Vaccines and Pediatrics, Pearl River, NY (JH, GS, FM, DM, IC, trials began in 1911, there is still no routinely recom- RK, WW); University of Pennsylvania, School of Medicine, Phil- mended pneumococcal vaccine for use in childhood. The adelphia, PA (RA); and Vanderbilt University Medical Center, Nashville, TN (KE). currently available 23-valent pneumococcal polysac- *Members of the Northern California Kaiser Permanente charide vaccine is not effective in children younger Vaccine Study Center Group: Drs. Janet Aguilar, Marissa Bar- than 2 years of age in whom 80% of invasive pneumo- tlett, Randy Bergen, Mel Burman, Steve Dorfman, Wayne Easter, Annette Finkel, Hervey Froehlich, James Glauber, Arnd Herz, coccal disease in childhood occurs. This vaccine has David Honeychurch, Robert Kleinrock, Irene Landaw, Allan also not been effective in the control of otitis media in Lavetter, Chinh Le, Steve McMurtry, Pius Morozumi, Pat Mullin, children. Michael Rehbein, Richard Rossin, Garwin Soe, Irene Takahashi, Gail Udkow, Robert Whitson. During recent years there has been considerable Key words: Heptavalent pneumococcal conjugate vaccine, effi- effort devoted toward developing a pneumococcal vac- cacy, safety, immunogenicity. cine that is effective in infants and children. After the Address for reprints: Steve Black, M.D., Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, Oakland, CA 94612. Fax licensure of conjugate Haemophilus influenzae type b 510-267-7524; E-mail [email protected]. (Hib) vaccines in late 1990, there has been a Ͼ98% 187 188 THE PEDIATRIC INFECTIOUS DISEASE JOURNAL Vol. 19, No. 3, March, 2000 elimination of Hib disease in this country.1 This leaves were administered at the recommended ages: diphthe- the pneumococcus as the most common cause of bacte- ria-tetanus toxoid-whole cell pertussis vaccine (DTwP) rial meningitis in young children. In addition there has or diphtheria-tetanus toxoid-acellular pertussis vac- been a rapid emergence of drug-resistant pneumococci cine (DTaP); oral poliovirus vaccine or inactivated that have caused invasive infection worldwide and in poliovirus vaccine; Hib; hepatitis B; measles-mumps- the United States.2 The increasing prominence of rubella vaccine; varicella. Initially all subjects received pneumococcal infections and of antimicrobial resis- TETRAMUNE (a vaccine combining Haemophilus b tance has emphasized the need for the development of conjugate and DTwP) into the opposite leg and oral an effective vaccination program to reduce the risk of poliovirus vaccine concurrently. When recommenda- pneumococcal disease in childhood. tions changed the protocol was amended to allow ad- The pneumococcus is responsible for a wide spec- ministration of DTaP and inactivated poliovirus vac- trum of infection ranging from asymptomatic carriage cine. Vaccines not given concomitantly were given at to overwhelming sepsis. Unlike Hib, where only one least 2 weeks apart from study vaccine. serotype accounted for virtually all H. influenzae dis- Efficacy. The primary endpoint for the evaluation of Ͼ ease, there are 90 described serotypes of the pneumo- efficacy of the pneumococcal conjugate vaccine was the coccus, many of which cause disease in adults and protective efficacy of the heptavalent pneumococcal children. However, within the US seven serotypes are conjugate vaccine against invasive pneumococcal dis- responsible for 83% of invasive disease in children ease caused by vaccine serotypes. Secondary endpoints younger than 4 years of age. included the efficacy of the vaccine against clinical We report the results of the Kaiser Permanente trial episodes of otitis media as defined below. An additional evaluating the efficacy, safety and immunogenicity of outcome, pneumonia, will be reported separately. the heptavalent pneumococcal conjugate vaccine Active surveillance for cases of invasive pneumococ- (Wyeth; PNCRM7) conducted in Northern California cal disease in the study population was conducted between October, 1995, and August, 1998, and the using automated clinical and laboratory databases. posttrial blinded efficacy follow-up through April 20, Invasive pneumococcal disease was defined as a posi- 1999. tive culture of Streptococcus pneumoniae from a nor- METHODS mally sterile body fluid obtained from a child present- ing with an acute illness compatible with pneumococcal This study was a randomized, double blind trial disease. To be included in the main efficacy analysis, conducted at 23 medical centers within Northern Cal- cases must have been caused by a pneumococcal sero- ifornia Kaiser Permanente (NCKP). The study was type included in the vaccine, must have occurred longer approved by the Institutional Review Board of the Kaiser Foundation Research Institute. Written in- than 14 days after the third dose of study vaccine and formed consent was obtained from parents or guard- must have occurred in subjects vaccinated according to ians. A Study Advisory Committee (Drs. Donna Ambro- protocol. In addition potential cases were tested for sino, William Blackwelder and Jerome Klein) immunocompetence evaluated by obtaining quantita- monitored the conduct of the study and functioned as a tive immunoglobulins, a complete blood count with Safety Monitoring Committee. differential and CD4/CD8 cell counts. Healthy infants were randomized 1:1 to receive ei- This trial incorporated a sequential design with an ther the heptavalent pneumococcal conjugate or the interim evaluation by the Study Advisory Committee meningococcus type C conjugate vaccine at 2, 4, 6 and at 17 cases in fully vaccinated per protocol cases of 12 to 15 months of age. Children with sickle cell invasive disease caused by vaccine serotype in fully disease, known immunodeficiency, any serious chronic vaccinated immunocompetent children. For each child or progressive disease, a history of seizures or a history follow-up ended for the main efficacy analysis at the of either pneumococcal or meningococcal disease were earliest of the following dates: the onset of invasive excluded. pneumococcal disease of any serotype; the child died; or The pneumococcal conjugate vaccine contained 2␮g at the end of the trial. A child younger than 16 months each of saccharides of serotypes 4, 9V, 14, 18C, 19F and of age was considered fully vaccinated if the child had 23F and 4␮g of 6B coupled to the protein carrier received three or more doses of vaccine, and a child Ն16 CRM197 (a nontoxic mutant of diphtheria toxin). The months of age was considered fully vaccinated after control meningococcal
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