SEATTLE – OCTOBER 08, 2018
An HIV Vaccine Trials Network (HVTN)-funded pilot study was conducted in South Africa to test the development and implementation of a basic mobile phone-based tool to collect data from adult participants enrolled in a phase 1/2a, randomized, controlled double-blind trial called HVTN 108. Collecting data on specific signs and symptoms after an experimental vaccine regimen is administered to study participants is an essential part of safety monitoring in a clinical trial. A number of ongoing HIV vaccine trials in Sub-Saharan Africa collect study participant data through “hardcopy tools” using a pen and paper.
The authors of a protocol published in the Journal of Medical Internet Research: Research Tools, October 08, postulate that results of the study, A Pilot Study of Mobile Technology to Assess Reactogenicity (pMOTAR), will lay the framework to assist research staff and study participants in collecting and objectively grading symptoms. Ultimately, researchers aim to determine if the accuracy and completeness of the mobile phone data are superior to that collected using the “hardcopy tools.” pMOTAR is completed, and data cleaning and analysis are underway; findings are expected by the end of 2018.
pMOTAR tested the new recording tool during HVTN 108, an ongoing trial designed to evaluate the safety, tolerability and immunogenicity of an HIV clade C DNA and protein-based vaccine adjuvanted with MF59 or AS01B in healthy, HIV-uninfected adult participants. Currently participants in the HVTN 108 trial use a thermometer to take their temperature, a ruler to measure any visible signs such as redness and swelling on their arm where the investigational vaccine was injected, and use a standardized set of symptom criteria to grade the severity of their symptoms. Participants asses their symptoms every day for seven days after receiving each injection and, on return to the clinic, undergo a symptom reconciliation process to verify data documented using the “hardcopy tools.”
pMOTAR aims to provide an alternative solution that can resolve circumstances in clinical trials when participants are difficult to contact. The mobile phone-based data collection tool may also be helpful in circumstances in which study participants do not have their “hardcopy tools” on hand during a site visit or when study participants have to recall information about their symptoms two weeks after receiving study product. pMOTAR is an outcome of the HVTN Initiatives Program (HIP), which supports early stage investigators in pursuit of answering new exploratory research questions.
“The application of rapidly emerging technology must keep pace with recent developments in the HIV preventive vaccine field to facilitate collection of key safety information,” said Kathryn Mngadi M.D., lead author of the study and Principal Investigator at the Aurum Institute, South Africa.
The need to consistently track safety events in the number of vaccine trials currently underway demands more accurate, efficient methods of data collection as an essential part of safety monitoring after study participants have received vaccines. The HVTN 108 trial includes four vaccination visits in a six-month period. pMOTAR tested two consecutive vaccination timepoints, months 3 and 6. Interviews to determine the feasibility and acceptability of pMOTAR were assessed through surveys with study participants and research staff.
“HIP provides investigators a unique opportunity to conduct innovative, exploratory research that might otherwise not receive funding from traditional sources. HIP research is pioneering and can take science in a new direction,” said Danna Flood, HVTN Director for Training, Evaluation and IT.
“Mobile technology offers the ability to get direct participant data in a convenient, timely and accurate fashion,” said Larry Corey, M.D., Principal Investigator of the HVTN, virologist and faculty member at Fred Hutchinson Cancer Research Center.
The HVTN 108 trial started enrollment in December 2016, and the trial results are expected to be announced in early 2020.
HVTN 108, together with other HIV vaccine clinical trials such as HVTN 100 and HVTN 702, is funded as part of a larger HIV vaccine research endeavor led by the Pox-Protein Public-Private Partnership, or P5—a diverse group of public and private organizations committed to building on the success of the RV144 trial—the first, and to date only, large clinical trial to demonstrate modest efficacy for an investigational HIV vaccine. The P5 aims to produce an HIV vaccine that could have a significant public health benefit in southern Africa and to advance scientists’ understanding of the immune responses associated with preventing HIV infection. P5 members include the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, the Bill & Melinda Gates Foundation, the South African Medical Research Council, HVTN, Sanofi Pasteur, GSK and the U.S. Military HIV Research Program.
Access to manuscript:
- NIAID, award number UM1 AI068614 [LOC: HIV Vaccine Trials Network] as part of the HVTN Initiatives Program (HIP)
Kathryn Mngadi (MBChB, MPhil Pall Med, Dip HIV Man SA, Dip Epi, Dip Clin Trials); Yajna Duki (MMedSc Cardiology); Douglas Grove (MS); Jessica Andriesen (PhD); Bhavna Maharaj (B Pharm)
About Fred Hutchinson Cancer Research Center
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network.
About the HVTN Initiatives Program (HIP)
HIP supports novel investigator-driven research proposals for projects within the scope of the HVTN research agenda using HVTN procured clinical, laboratory, and/or behavioral data as well as pilot proposals. HIP Investigators conduct year-long projects that are exploratory, ground breaking, or extend previous HIV vaccine discoveries in new directions. Please direct any enquiries about HIP to Jenna Udren at firstname.lastname@example.org.
HVTN: Director of Communications
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