PCV21 for Pneumonia Vaccine
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
How is the PCV21 vaccine different from other pneumonia vaccines?
The PCV21 vaccine is unique because it is designed to cover more types of pneumococcal bacteria than existing vaccines, potentially increasing protection, especially in older adults and those at higher risk, like Black older adults.
58121315Is the PCV21 vaccine for pneumonia generally safe for humans?
Pneumococcal conjugate vaccines, like PCV7 and PCV13, have been shown to be generally safe in humans, with mild and self-limited reactions such as local reactions and fever. No major safety problems have been identified, although there may be a possible association with reactive airway disease and Kawasaki disease that requires further investigation.
12379What data supports the effectiveness of the treatment PCV21 for pneumonia?
Research shows that pneumococcal conjugate vaccines (PCVs) like PCV13 have been effective in reducing pneumonia hospitalizations and the burden of invasive pneumococcal diseases. This suggests that PCV21, which likely includes more serotypes, could further enhance protection against pneumonia.
46101114Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether participants must stop taking their current medications. However, if you are on immunosuppressive therapy, long-term systemic corticosteroids, or anticoagulants, you may not be eligible to participate.
Eligibility Criteria
This trial is for healthy infants aged approximately 2 months (42 to 89 days) at the time of inclusion. They must be deemed healthy by a medical evaluation, which includes their medical history and physical examination.Inclusion Criteria
I am between 42 and 89 days old today.
Participant Groups
The study tests if the PCV21 vaccine is safe and effective in producing antibodies when given after doses of an already licensed 20-valent pneumococcal vaccine. Infants will receive vaccines at around 2, 4, 6, and 12-15 months old alongside routine pediatric vaccines.
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: 20vPCV-20vPCV-PCV21-PCV21Experimental Treatment10 Interventions
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group II: Group 1: 20vPCV-PCV21-PCV21-PCV21Experimental Treatment10 Interventions
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group III: 20vPCV-20vPCV-20vPCV-PCV21Experimental Treatment10 Interventions
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
Group IV: 20vPCV-20vPCV-20vPCV-20vPCVActive Control9 Interventions
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
~SUNY Upstate Medical University- Site Number : 8400015Syracuse, NY
Kid's Way Pediatrics- Site Number : 8400013Hermitage, PA
University of Texas Medical Branch at Galveston- Site Number : 8400005League City, TX
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Who is running the clinical trial?
SanofiLead Sponsor
References
The safety of 7-valent pneumococcal conjugate vaccine. [2007]Streptococcus pneumoniae is one of the most important bacterial pathogens of young children. Currently, there are several conjugate vaccines against S. pneumoniae in various stages of laboratory development, clinical evaluation or currently licensed. Heptavalent pneumococcal conjugate vaccine (Wyeth Lederle; PCV-7) is the only currently approved pneumococcal conjugate vaccine indicated against invasive pneumococcal disease for children younger than two years of age. Safety studies have shown that the PCV-7 is acceptably safe when administered alone, simultaneously with other childhood vaccines or in combination with Haemophilus influenzae type b conjugate vaccines. In addition, PCV-7 vaccine was generally safe and immunogenic among infants infected with HIV and those with sickle cell disease. Surveillance studies to monitor the serotype distribution in invasive pneumococcal disease is important to determine that PCV-7 continues to be the optimal vaccination for prevention of pneumococcal invasive disease.
Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006). [2022]In this paper we present an overview of the literature on efficacy and safety trials of the various pneumococcal conjugate vaccines on the market (PCV7) and in development (PCV9, PCV11 and allegedly PCV10 and PCV13), as well as of observations from post-licensure studies. Seven- (PCV7) and nine-valent PCV (PCV9) are reported to be sufficiently immunogenic after administration of a 3+1 schedule in infants in various RCTs. PncOMPC (PCV7 with a protein of N. meningitidis as a carrier) is less immunogenic, though this may have no repercussions for the protective efficacy against clinical disease. PCV7 is 82-97% efficacious against vaccine serotype (VT) IPD, 90% efficacious against (clinically diagnosed) pneumococcal pneumonia, and, like the 11-valent PCV, 57% efficacious against VT acute otitis media. Naturally, it would be of paramount public health interest if the same levels of efficacy and effectiveness could be achieved with fewer doses. Trials studying 2+1 vaccination schedules for PCV7 and PCV9 generally show that the percentage of infants achieving the protective cut-off set by the World Health Organization (WHO) 1 month after the last priming dose, is comparable to that found at the same time point in studies administering 3+1 schedules. PCVs are generally very well tolerated and safe, also when co-administered with other childhood vaccines. As more and more countries are using these vaccines routinely, post marketing surveillance studies will further establish the safety profile of PCVs.
Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. [2021]A 7-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) was licensed in the United States of America in 2000, but no comprehensive postmarketing review of safety has been carried out. We conducted a systematic review of the safety of PCV7 and other pneumococcal conjugate vaccines. A total of 42 studies were included in the review. Reactogenicity data from some randomized trials suggest that PCV7 may result in more local reactions and fever than certain comparison vaccines. However, the reactions were mild and self-limited, and PCV7 did not carry an increased risk of severe injection-site reactions or high fever. Some, although not all, of the randomized trials in children found that mild local and systemic reactions associated with PCV7 may increase with the number of doses, at least over the three-dose primary series. In addition, PCV7 and other pneumococcal conjugate vaccines were found to have tolerable reactogenicity in Native American and African populations and in medically high-risk groups for which pneumococcal vaccination is recommended. Two of the largest studies of PCVs, one involving PCV7 and the other, PCV9, found a statistically significant increased risk of hospitalization for reactive airway disease, including asthma. Another large trial of PCV9, however, did not find an increased risk of asthma. In conclusion, this review of the evidence did not identify any major safety problems with PCV7 or any other pneumococcal conjugate vaccine, with the possible exception of reactive airway disease, which may bear further scrutiny as additional data become available.
Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. [2019]Pneumococcal conjugate vaccine (PCV) is an effective way to prevent invasive pneumococcal diseases in high risk populations. The efficacy of this vaccine in paediatric oncology patients remains unknown.
Advances in pneumococcal disease prevention: 13-valent pneumococcal conjugate vaccine for infants and children. [2011]A 13-valent pneumococcal conjugate vaccine (PCV13), developed with the same chemistry used for the 7-valent PCV vaccine (PCV7) and with the goal of expanding serotype coverage, was clinically evaluated in the United States and Europe and found to induce capsular-specific antibody responses comparable to those of PCV7 for the common serotypes, with robust responses to the 6 additional serotypes. In addition, PCV13 has a similar safety profile to PCV7 and can be given routinely to infants and children, ideally as a 3-dose primary series in the first year of life, with a booster dose in the second year. Children who have initiated their vaccination program with PCV7 can transition to PCV13 at any point in the schedule. Children aged ≥15 months who have been completely vaccinated with PCV7 can receive a single dose of PCV13 to induce immunity to the 6 additional serotypes.
Benefit of conjugate pneumococcal vaccination in preventing influenza hospitalization in children: a case-control study. [2013]The pneumococcal conjugate vaccine (PCV) might prevent hospitalizations in children because of the role of Streptococcus pneumoniae in the complications of influenza infection. We investigated the benefit of PCV vaccination in preventing influenza hospitalization in children
Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. [2022]Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13(®) (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States. The historical unexposed population was children of the same age who received the 7-valent pneumococcal conjugate vaccine Prevnar 7(®) (PCV7) in 2007 (or 2005 depending on the outcome of interest) to 2009. The risk of pre-specified adverse events in the risk window following PCV13 was repeatedly compared to that in the historical comparison group. The number of doses included in the study was 599,229. No increased risk was found for febrile seizures, urticaria or angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis. An increased risk for encephalopathy was not confirmed following the medical record review. The relative risk for Kawasaki disease in 0-28 days following vaccination was 1.94 (95% confidence interval: 0.79-4.86), comparing PCV13 to PCV7. Comparing to PCV7 vaccine, we identified no significant increased risk of pre-specified adverse events in the Vaccine Safety Datalink study cohort. The possible association between PCV13 and Kawasaki disease may deserve further investigation.
Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. [2022]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.
Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. [2018]In clinical trials of Pneumococcal Conjugate Vaccines (PCV), some adverse events have been reported more frequently in the PCV vaccinated. Ten-valent PCV (PCV10) was introduced into the Finnish National Vaccination Programme (NVP) in September 2010.
Impact of pneumococcal conjugate vaccine on pneumonia hospitalization and mortality in children and elderly in Ecuador: Time series analyses. [2021]Pneumococcal conjugate vaccines (PCV) reduce the burden of invasive pneumococcal disease and pneumonia hospitalizations. However, there is limited evidence of the effect of PCVs on pneumonia mortality in children. It is anticipated that indirect effects resulting from PCV use among children might further reduce the remaining burden of adult pneumococcal disease caused by pneumococcal serotypes contained in PCV. Whether this will result in reduced pneumonia mortality in children and adults is still not known.
Thirteen-Valent Pneumococcal Conjugate Vaccine-Induced Immunoglobulin G (IgG) Responses in Serum Associated With Serotype-Specific IgG in the Lung. [2023]Pneumococcal conjugate vaccine (PCV) efficacy is lower for noninvasive pneumonia than invasive disease. In this study, participants were immunized with 13-valent PCV (PCV13) or hepatitis A vaccine (control). Bronchoalveolar lavage samples were taken between 2 and 6 months and serum at 4 and 7 weeks postvaccination. In the lung, anti-capsular immunoglobulin G (IgG) levels were higher in the PCV13 group compared to controls for all serotypes, except 3 and 6B. Systemically, IgG levels were elevated in the PCV13 group at 4 weeks for all serotypes, except serotype 3. IgG in bronchoalveolar lavage and serum positively correlated for nearly all serotypes. PCV13 shows poor immunogenicity to serotype 3, implying lack of protective efficacy. Clinical Trials Registration. ISRCTN 45340436.
A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. [2022]Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional serotypes not in PCV13 continue to present a substantial disease burden. The 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13. As part of the phase 3 clinical development program, the current study assessed consistency of immune responses across 3 lots of PCV20 and described the safety profile of PCV20.
A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. [2022]A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination.
The impact of pneumococcal conjugate vaccine on the prevalence and severity of hospitalizations for pneumonia in children. [2022]Pneumococcal conjugate vaccines (PCV) were introduced into the Israeli national immunization plan starting with the heptavalent PCV7 in 2009 and then PCV13 in the late 2010. The objective of this study was to determine the vaccines' impact on hospitalization rates for community-acquired pneumonia on the severity of the pneumonia episodes and upon pneumococcal serotype distribution. We retrospectively reviewed all children hospitalized in our institution with pneumonia, aged between 1 and 16 years, between the years 2006 and 2015. Demographic, clinical, and laboratory data between three time periods: pre-PCV, PCV7, and PCV13, were compared. During the study period, 1375 children were hospitalized with pneumonia. A gradual decline in hospitalization rates due to pneumonia was observed starting in 2006 in the pre-PCV period and continued until after the introduction of PCV13. A similar trend was observed in pneumonias with a culture positive for S. pneumoniae. Pleural effusion was observed in 24% of all pneumonias, and this percentage was stable throughout the study period. The average age at hospitalization increased during the study period, as did the average duration of hospital stay. Pneumococcal serotypes included in the vaccine were isolated less frequently during the study and non-vaccine serotypes tended to appear more frequently. Pediatric pneumonia hospitalization rates continued to decline since the introduction of PCV without increasing the frequency of complications. Pneumococcal serotype distribution shifted in parallel. Our findings confirm the efficacy of PCV and support the evidence to include more serotypes in the next generation of PCV.
Cost-effectiveness of an in-development adult-formulated pneumococcal vaccine in older US adults. [2023]CDC pneumococcal vaccination recommendations for older adults now include either 15- or 20-valent pneumococcal conjugate vaccine (PCV15/PCV20). However, an in-development 21-valent vaccine (PCV21), formulated based on adult pneumococcal disease epidemiology, could substantially increase coverage of disease-causing pneumococcal serotypes, particularly in Black older adults, who are at greater risk. The potential public health impact and cost-effectiveness of PCV21 compared to currently recommended vaccines in older adults is unclear.