Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial
BACKGROUND: Needle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity. Here we report the first comparison of Biojector and needle administration of a candidate rAd5 HIV vaccine.
METHODS: Thirty-one adults, 18-55 years, 20 naive and 11 prior rAd5 vaccine recipients were randomized to receive single rAd5 vaccine via needle or Biojector IM injection at 1010 PU in a Phase I open label clinical trial. Solicited reactogenicity was collected for 5 days; clinical safety and immunogenicity follow-up was continued for 24 weeks.
RESULTS: Overall, injections by either method were well tolerated. There were no serious adverse events. Frequency of any local reactogenicity was 16/16 (100%) for Biojector compared to 11/15 (73%) for needle injections. There was no difference in HIV Env-specific antibody response between Biojector and needle delivery. Env-specific antibody responses were more than 10-fold higher in subjects receiving a booster dose of rAd5 vaccine than after a single dose delivered by either method regardless of interval between prime and boost.
CONCLUSIONS: Biojector delivery did not improve antibody responses to the rAd5 vaccine compared to needle administration. Homologous boosting with rAd5 gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity.
TRIAL REGISTRATION: Clinicaltrials.gov NCT00709605 NCT00709605.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2014 |
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| Erschienen: |
2014 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
PloS one - 9(2014), 9 vom: 29., Seite e106240 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sarwar, Uzma N [VerfasserIn] |
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| Links: |
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| Themen: |
AIDS Vaccines |
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| Anmerkungen: |
Date Completed 15.06.2015 Date Revised 21.10.2021 published: Electronic-eCollection ClinicalTrials.gov: NCT00709605 Citation Status MEDLINE |
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| doi: |
10.1371/journal.pone.0106240 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM242307469 |
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| 100 | 1 | |a Sarwar, Uzma N |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial |
| 264 | 1 | |c 2014 | |
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| 500 | |a Date Completed 15.06.2015 | ||
| 500 | |a Date Revised 21.10.2021 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT00709605 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Needle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity. Here we report the first comparison of Biojector and needle administration of a candidate rAd5 HIV vaccine | ||
| 520 | |a METHODS: Thirty-one adults, 18-55 years, 20 naive and 11 prior rAd5 vaccine recipients were randomized to receive single rAd5 vaccine via needle or Biojector IM injection at 1010 PU in a Phase I open label clinical trial. Solicited reactogenicity was collected for 5 days; clinical safety and immunogenicity follow-up was continued for 24 weeks | ||
| 520 | |a RESULTS: Overall, injections by either method were well tolerated. There were no serious adverse events. Frequency of any local reactogenicity was 16/16 (100%) for Biojector compared to 11/15 (73%) for needle injections. There was no difference in HIV Env-specific antibody response between Biojector and needle delivery. Env-specific antibody responses were more than 10-fold higher in subjects receiving a booster dose of rAd5 vaccine than after a single dose delivered by either method regardless of interval between prime and boost | ||
| 520 | |a CONCLUSIONS: Biojector delivery did not improve antibody responses to the rAd5 vaccine compared to needle administration. Homologous boosting with rAd5 gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity | ||
| 520 | |a TRIAL REGISTRATION: Clinicaltrials.gov NCT00709605 NCT00709605 | ||
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, U.S. Gov't, Non-P.H.S. | |
| 650 | 7 | |a AIDS Vaccines |2 NLM | |
| 650 | 7 | |a HIV Antibodies |2 NLM | |
| 700 | 1 | |a Novik, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Enama, Mary E |e verfasserin |4 aut | |
| 700 | 1 | |a Plummer, Sarah A |e verfasserin |4 aut | |
| 700 | 1 | |a Koup, Richard A |e verfasserin |4 aut | |
| 700 | 1 | |a Nason, Martha C |e verfasserin |4 aut | |
| 700 | 1 | |a Bailer, Robert T |e verfasserin |4 aut | |
| 700 | 1 | |a McDermott, Adrian B |e verfasserin |4 aut | |
| 700 | 1 | |a Roederer, Mario |e verfasserin |4 aut | |
| 700 | 1 | |a Mascola, John R |e verfasserin |4 aut | |
| 700 | 1 | |a Ledgerwood, Julie E |e verfasserin |4 aut | |
| 700 | 1 | |a Graham, Barney S |e verfasserin |4 aut | |
| 700 | 0 | |a VRC 015 study team |e verfasserin |4 aut | |
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