Evidence map›Paper›PMID 30883270›Full record

ArticleHuman vaccines & immunotherapeutics2019

Evaluation of the thermal stability and the protective efficacy of spray-dried HPV vaccine, Gardasil® 9.

Nitesh K Kunda, Julianne Peabody, Lukai Zhai, Dominique N Price, Bryce Chackerian, Ebenezer Tumban, Pavan Muttil

Open access · bronzeAbstract readEvaluation Study
In one paragraph

Article in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 30 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Nitesh K Kundaa Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico , Albuquerque , NM , USA.ORCID 0000-0002-3063-0375
Julianne Peabodyc Department of Molecular Genetics and Microbiology, University of New Mexico School of Medicine , Albuquerque , NM , USA.
Lukai Zhaid Department of Biological Sciences, Michigan Technological University , Houghton , MI , USA.
Dominique N Pricea Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico , Albuquerque , NM , USA.
Bryce Chackerianc Department of Molecular Genetics and Microbiology, University of New Mexico School of Medicine , Albuquerque , NM , USA.
Ebenezer Tumband Department of Biological Sciences, Michigan Technological University , Houghton , MI , USA.ORCID 0000-0001-7484-2081
Pavan Muttila Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico , Albuquerque , NM , USA.
University of New Mexico · USMichigan Technological University · USSt. John's University · US

Funding

The EPI-STI Biostatistics and Bioinformatics Core (Cuzick/Wheeler)U19AI113187 · NIAID · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI KONG, ALBERTA SUM-YU · 2014 to 2018
$12.6M
Development of a Multi-epitope L2 Bacteriophage VLPs Vaccine to Enhance Protection against Oral HPV Infections in HIV patientsR15DE025812 · NIDCR · MICHIGAN TECHNOLOGICAL UNIVERSITY · PI TUMBAN, EBENEZER · 2016 to 2016
$457k
NIAID NIH HHS U19 AI113187NIDCR NIH HHS R15 DE025812
6 · The paper itself

Abstract

High-risk human papillomavirus (HPV) types are responsible for nearly all cases of cervical cancers. Cervarix® and Gardasil® 9 are the current prophylactic vaccines available that protect against the majority of HPVs associated with cancer. Although these vaccines are highly effective, HPV vaccine implementation has been slow, particularly in low-and-middle income countries. Major barriers to the widespread availability of the HPV vaccines is its cost and the requirement for continuous refrigeration (2-8°C). Here, we used spray drying along with stabilizing excipients to formulate a thermostable Gardasil® 9 vaccine. We evaluated the immunogenicity and protective efficacy of the vaccine in mice immediately after spray drying and following storage for three months at 4°C, 25°C, and 40°C. The immunogenicity studies were performed using Gardasil® 9 as a whole antigen, and not individual HPV types, for ELISA. At the dose tested, the spray dried vaccine conferred protection against HPV following storage at temperatures up to 40°C. In addition to the spray-dried vaccine, our studies revealed that the Gardasil® 9 vaccine, as currently marketed, may be stored and transported at elevated temperatures for up to 3 months without losing efficacy, especially against HPV16. This study is critical, as a thermostable vaccine will decrease vaccine cost associated with cold-chain maintenance and could increase vaccine access and coverage, especially in remote regions of the world.

Indexed as

TemperatureAnimalsAntibodies, ViralChemistry, PharmaceuticalFemaleHygroscopic AgentsInjections, IntramuscularMiceMice, Inbred BALB CPapillomavirus VaccinesPowdersRefrigerationVaccinationAntibodies, ViralHuman Papillomavirus Recombinant Vaccine nonavalentHygroscopic AgentsPapillomavirus VaccinesPowderscervical cancercold-chainGardasil® 9 vaccinehuman papillomavirusspray dryingthermostable

Identifiers

PMID30883270
PMCPMC6746511
OpenAlexW2921511917

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.