The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle>
Immunogenicity and safety of ACWY-TT compared with licensed ACWY polysaccharide vaccine (MenPS) in healthy adults, and lot-to-lot consistency of three ACWY-TT lots were evaluated in a phase 3, open, controlled study. Adults aged 18–55 y were randomized to receive ACWY-TT (one of three lots) or MenPS...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2012-07-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.4161/hv.20211 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846114553928089600 |
|---|---|
| author | Ghassan Dbaibo Noel Macalalad Mari Rose Aplasca-De Los Reyes Efren Dimaano Véronique Bianco Yaela Baine Jacqueline M. Miller |
| author_facet | Ghassan Dbaibo Noel Macalalad Mari Rose Aplasca-De Los Reyes Efren Dimaano Véronique Bianco Yaela Baine Jacqueline M. Miller |
| author_sort | Ghassan Dbaibo |
| collection | DOAJ |
| description | Immunogenicity and safety of ACWY-TT compared with licensed ACWY polysaccharide vaccine (MenPS) in healthy adults, and lot-to-lot consistency of three ACWY-TT lots were evaluated in a phase 3, open, controlled study. Adults aged 18–55 y were randomized to receive ACWY-TT (one of three lots) or MenPS. Serum bactericidal antibodies (rSBA) were measured pre- and 1 mo post-vaccination. Adverse events (AEs) were assessed 4 d (solicited symptoms) and 31 d (unsolicited symptoms) post-vaccination. Serious AEs were reported up to 6 mo after vaccination. The number of vaccinated subjects was 1247 (ACWY-TT, n = 935; MenPS, n = 312). ACWY-TT lot-to-lot consistency and non-inferiority of ACWY-TT as compared with MenPS groups were demonstrated according to pre-specified criteria. The percentages of subjects with a vaccine response (VR = rSBA titer ≥ 1:32 in initially seronegative; ≥ 4-fold increase in initially seropositive) to ACWY-TT vs. MenPS were 80.1%/69.8% (serogroup A), 91.5%/ 92.0% (C), 90.2%/85.5% (W-135), 87.0%/78.8% (Y). Exploratory analyses showed that for serogroups A, W-135 and Y, VR rates and GMTs were significantly higher for ACWY-TT compared with MenPS. For each serogroup, ≥ 98.0% of subjects had rSBA titers ≥ 1:128. Grade 3 solicited AEs were reported in ≤ 1.6% of subjects in any group. The immunogenicity of ACWY-TT vaccine was non-inferior to MenPS for all four serogroups in adults, with significantly higher VR rates to serogroups A, W-135 and Y and an acceptable safety profile. Consistency of 3 ACWY-TT production lots was demonstrated. These data suggest that, if licensed, ACWY-TT conjugate vaccine may be used for protection against invasive meningococcal disease in healthy adults. This study is registered at clinicaltrials.gov NCT00453986 |
| format | Article |
| id | doaj-art-dc0b899c83d64f53b14a9db04adbd3a0 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2012-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-dc0b899c83d64f53b14a9db04adbd3a02024-12-20T09:34:46ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2012-07-018787388010.4161/hv.20211The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle>Ghassan Dbaibo0Noel Macalalad1Mari Rose Aplasca-De Los Reyes2Efren Dimaano3Véronique Bianco4Yaela Baine5Jacqueline M. Miller6American University of Beirut Medical Center; Riad El Solh; Beirut, LebanonDe La Salle University Medical Center Congressional Road; Dasmarinas, Cavite, PhilippinesResearch Institute for Tropical Medicine; Filinvest Corporate City; Alabang, Muntinlupa City, PhilippinesSan Lazaro Hospital San Lazaro Compound; Sta. Cruz, Manila, PhilippinesGlaxoSmithKline Biologicals; Wavre, BelgiumGlaxoSmithKline Biologicals; King of Prussia, Philadelphia, PA USAGlaxoSmithKline Biologicals; King of Prussia, Philadelphia, PA USAImmunogenicity and safety of ACWY-TT compared with licensed ACWY polysaccharide vaccine (MenPS) in healthy adults, and lot-to-lot consistency of three ACWY-TT lots were evaluated in a phase 3, open, controlled study. Adults aged 18–55 y were randomized to receive ACWY-TT (one of three lots) or MenPS. Serum bactericidal antibodies (rSBA) were measured pre- and 1 mo post-vaccination. Adverse events (AEs) were assessed 4 d (solicited symptoms) and 31 d (unsolicited symptoms) post-vaccination. Serious AEs were reported up to 6 mo after vaccination. The number of vaccinated subjects was 1247 (ACWY-TT, n = 935; MenPS, n = 312). ACWY-TT lot-to-lot consistency and non-inferiority of ACWY-TT as compared with MenPS groups were demonstrated according to pre-specified criteria. The percentages of subjects with a vaccine response (VR = rSBA titer ≥ 1:32 in initially seronegative; ≥ 4-fold increase in initially seropositive) to ACWY-TT vs. MenPS were 80.1%/69.8% (serogroup A), 91.5%/ 92.0% (C), 90.2%/85.5% (W-135), 87.0%/78.8% (Y). Exploratory analyses showed that for serogroups A, W-135 and Y, VR rates and GMTs were significantly higher for ACWY-TT compared with MenPS. For each serogroup, ≥ 98.0% of subjects had rSBA titers ≥ 1:128. Grade 3 solicited AEs were reported in ≤ 1.6% of subjects in any group. The immunogenicity of ACWY-TT vaccine was non-inferior to MenPS for all four serogroups in adults, with significantly higher VR rates to serogroups A, W-135 and Y and an acceptable safety profile. Consistency of 3 ACWY-TT production lots was demonstrated. These data suggest that, if licensed, ACWY-TT conjugate vaccine may be used for protection against invasive meningococcal disease in healthy adults. This study is registered at clinicaltrials.gov NCT00453986https://www.tandfonline.com/doi/10.4161/hv.20211ACWY-TT vaccineNeisseria meningitidisadultbactericidal activityconjugate vaccineimmunogenicity |
| spellingShingle | Ghassan Dbaibo Noel Macalalad Mari Rose Aplasca-De Los Reyes Efren Dimaano Véronique Bianco Yaela Baine Jacqueline M. Miller The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle> Human Vaccines & Immunotherapeutics ACWY-TT vaccine Neisseria meningitidis adult bactericidal activity conjugate vaccine immunogenicity |
| title | The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle> |
| title_full | The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle> |
| title_fullStr | The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle> |
| title_full_unstemmed | The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle> |
| title_short | The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine<subtitle>A randomized, controlled non-inferiority study</subtitle> |
| title_sort | immunogenicity and safety of an investigational meningococcal serogroups a c w 135 and y tetanus toxoid conjugate vaccine acwy tt compared with a licensed meningococcal tetravalent polysaccharide vaccine subtitle a randomized controlled non inferiority study subtitle |
| topic | ACWY-TT vaccine Neisseria meningitidis adult bactericidal activity conjugate vaccine immunogenicity |
| url | https://www.tandfonline.com/doi/10.4161/hv.20211 |
| work_keys_str_mv | AT ghassandbaibo theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT noelmacalalad theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT mariroseaplascadelosreyes theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT efrendimaano theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT veroniquebianco theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT yaelabaine theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT jacquelinemmiller theimmunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT ghassandbaibo immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT noelmacalalad immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT mariroseaplascadelosreyes immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT efrendimaano immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT veroniquebianco immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT yaelabaine immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle AT jacquelinemmiller immunogenicityandsafetyofaninvestigationalmeningococcalserogroupsacw135andytetanustoxoidconjugatevaccineacwyttcomparedwithalicensedmeningococcaltetravalentpolysaccharidevaccinesubtitlearandomizedcontrollednoninferioritystudysubtitle |