This graphic provides a state of the field on vaccine research development programs, giving details on the Pox-Protein Public-Private Partnership trials testing canarypox-protein based vaccine candidates and the Jannssen development program of Ad26 vector + Mosaic immunogen vaccine strategy.
Vaccine Research Developing Programs
AIDS Vaccine Science: Hot Seat
This is training exercise designed to bring HIV vaccine research information to life.
Why We’re Hopeful this HIV Vaccine Awareness Day
HIV Vaccine Awareness Day (HVAD), an annual commemoration of the need for and commitment to the ongoing search for a vaccine, is on May 18. AVAC is pleased to join partners across the globe in observing the progress in vaccine research.
Over the last year, data from a range of studies have advanced our understanding of vaccine science, from “classic” vaccine strategies to newer approaches with broadly neutralizing antibodies (bNAbs). These include the launch of a clinical trial in South Africa testing a vaccine building on the success of RV144 in Thailand, as well as data on passive immunization with bNAbs. These advances and more will be featured in an upcoming AVAC webinar—Vaccines in Vivo: AIDS vaccine clinical trials in 2015—on May 18.
UPDATE: Slides and audio now available — click here.
The webinar is a continuation of a year-long series of web-based dialogues on HIV prevention and implementation, the most recent of which focused on advances in neutralizing antibody research and passive immunization. Click here to access the recording.
In addition to the webinar update next week, we are also releasing our annual HVAD Toolkit, which is designed to help explain vaccine science in simple language. This year’s edition includes a set of simplified, updated infographics, fact sheets and other tools outlining key advances in the field.
Click here to visit our HVAD page and download the toolkit.
The Toolkit includes the following resources:
- AIDS Vaccine Research 2015: An overview—Infographic highlighting the current state of the field and critical issues advocates should be tracking.
- AIDS Vaccines by the Numbers—One-page infographic depicting key data, including number of trials, funding, discoveries and more.
- AIDS Vaccine Science for Busy Advocates—One-pagers reviewing highlights, next steps and key terms
- Antibody Research: Progress on a powerful immune response
- Passive Immunization: An important piece of the puzzle
- AIDS Vaccines: The basics—Introductory PowerPoint slide set with basic concepts, an overview of research status and recent developments.
- AIDS Vaccines: An introductory fact sheet—Part of AVAC’s basic fact sheet series, a two-pager of basic information and research updates.
- AIDS Vaccines: Key messages—Bullet points on today’s pressing issues.
- AIDS Vaccine Science: Hot seat—Training exercise to bring the content to life.
We welcome any comments, questions, suggestions and requests for these materials; please be in touch. AVAC also maintains tables, timelines and other information about ongoing and planned vaccine and other HIV prevention trials at www.avac.org/pxrd.
We look forward to commemorating another HVAD with all of you as we continue to pursue the goal of a vaccine to prevent HIV.
Webinar: Why We’re Hopeful this HIV Vaccine Awareness Day
On Monday, May 18, advocates around the world will observe HIV Vaccine Awareness Day (HVAD)—an annual commemoration of the need for and commitment to the ongoing search for a vaccine. We invite you to join us on the day for a webinar—Vaccines in Vivo: Advances in AIDS Vaccine Research—at 10am US ET / 4pm South Africa / 5pm East Africa time (check www.timeanddate.com for your local time). We are also updating materials for vaccine advocates, including our “HVAD Toolkit” for those interested in easy-to-digest research updates.
This year brought the launch of long-awaited initiation of clinical trials building on positive results from the RV144 “Thai” trial. This effort is led by the Pox-Protein Public-Private Partnership (P5), including the the HIV Vaccine Trials Network, who will join the webinar to provide a status update of their current vaccine research and development program. We will also feature Janssen, part of Johnson & Johnson, to provide an overview of the research program they are moving forward that focuses on a cross-clade vaccine product.
Join this webinar if you’d like to understand:
- When and where the P5 trials are taking place?
- What questions will be asked in the P5 “licensure track” trials—designed to bring a product to market, and what will the “research” track address? [Click here for AVAC’s explanation of the dual tracks.]
- The pipeline beyond the P5 trials—including the candidate Janssen is developing
- The role for advocates in southern Africa and around the world in terms of keeping AIDS vaccine research on track
Click to register for the webinar.
This webinar will be the next installment in our Prevention on the Line series, a year-long dialogue on pressing issues in HIV prevention research and implementation.
For advocates planning HVAD activities or simply looking for an update on the latest in the field, AVAC is updating its “HVAD Toolkit”, which includes a range of materials with HIV vaccine research highlights. The updated Toolkit will be available shortly at www.avac.org/hvad. Please email us if you’re looking for a specific resource right away.
We look forward to commemorating another HVAD with all of you as we continue to work toward the ultimate goal of a vaccine to prevent HIV. AVAC would especially like to thank the Bill & Melinda Gates Foundation, International AIDS Vaccine Initiative, the US Agency for International Development, and our civil society partners in countries for supporting and partnering in HVAD and other vaccine advocacy initiatives.
We look forward to hearing your voices and questions in this discussion. And, as always, please email us at avac@avac.org with questions, comments and suggestions.
Selected Guide to Pipeline of Antibodies, Long-Acting ARVs and Vaccines
This graphic provides a quick primer on passive immunization with HIV-specific antibodies, long-acting antiretroviral injectables, and preventive vaccines, including a new, informative table reviewing the pipelines in research and development for all three research avenues.
New Frontiers in HIV Prevention, Treatment and Cure
It’s time to take an active interest in “passive immunization”—a scientific term for an expanding area of research that’s highly relevant to treatment, prevention and cure work. There are trials in humans happening in many regions of the world—and data are beginning to come in that advocates need to understand, analyze and consider.
AVAC hosted a webinar, New Frontiers in HIV Prevention, Treatment and Cure—An advocate’s webinar on passive immunization with a presentation from Dr. Sarah Schlesinger of Rockefeller University. Dr. Schlesinger provided an overview of recent developments across the field including new published data.
Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)
This webinar was just one in our year-long series, HIV Prevention on the Line. View webinars from the full series here.
The term passive immunization refers to the administration of laboratory-generated antibodies to people. It’s different from vaccine strategies, which teach our bodies how to make antibodies for ourselves.
Dr. Schlesinger is one of the authors of a recent study on passive immunization of a broadly neutralizing antibody (bNAb) called 3BNC117 in both HIV-negative individuals and people living with HIV. This was the first trial in humans of this particular bNAB. At least three other bNABs are currently in early phase clinical trials in humans. This research pipeline is exploring how passive immunization might be used as a treatment (to control HIV in people living with the virus); as a cure (to help clear HIV from viral reservoirs in people living with HIV); and as prevention.
Dr. Schlesinger provided a basic introduction to bNAbs and the ways that they are being studied, and described the work that she and her colleagues have recently published.
Further Reading
The most potent antibodies against HIV are known as broadly neutralizing antibodies—immune responses generated by a handful of people living with HIV. Scientists have analyzed blood from many people living with HIV and in a few have been able to find these bNABs that can block the activity of wide range of strains of HIV. In recent years, scientists have isolated a range of these potent bNAbs and have worked to modify them to make them even more effective, reduce the size of the dose needed for impact, and ensure that they are delivered to the sites of exposure—e.g., the vagina and rectum in the case of sexual exposure—where protection is needed most. Click here to see AVAC’s “Passive Immunization for Busy Advocates” resource, and click here for a recent presentation from Dr. Penny Moore at AVAC’s Advocacy Partners’ Forum.
Passive immunization using bNAbs is one of several strategies that is being explored for both prevention in people who are HIV-negative as well as treatment and cure strategies for people living with HIV. Long-acting injectable ARVs are also being studied in both populations, as are traditional vaccines. Want to understand the differences and the pipelines? Check out the section on injectable prevention in the recently released AVAC Report—and keep an eye out for the next issue of Px Wire, which will feature an extensive discussion of this expanding arena. Also, Richard Jefferys of the Treatment Action Group just published An HIV Cure and a Vaccine within the Next 15 Years?, a terrific overview of key concepts.
Px Wire April-June 2015, Vol. 8, No. 2
Px Wire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. In this issue, you’ll find updates and how WHO is approaching broader guidance on oral PrEP and a closer look at passive immunization.
Our centerspread provides a quick primer on passive immunization with HIV-specific antibodies, long-acting antiretroviral injectables, and preventive vaccines, including a new, informative table reviewing the pipelines in research and development for all three research avenues.
New Issue of Px Wire: Action on Oral PrEP and Updates on Antibodies
The new issue of Px Wire, AVAC’s quarterly newsletter on HIV prevention research and implementation, is now available.
In this issue, you’ll find:
- Updates on how WHO is approaching broader guidance on oral PrEP—and what advocates think should happen next.
- A closer look at passive immunization, an expanding area of research referring to the administration of laboratory-generated antibodies. Passive immunization is being explored in people living with HIV in attempts to help control viral replication and/or serve as part of a cure strategy. It is also being explored for HIV prevention.
- And this issue’s centerspread provides a quick primer on passive immunization with HIV-specific antibodies, long-acting antiretroviral injectables, and preventive vaccines, including a new, informative table reviewing the pipelines in research and development for all three research avenues.
New Overview of Cure and Vaccine Research from TAG
Richard Jefferys of Treatment Action Group, whose incredibly clear and detailed updates on immunology, virology and pathogensis (a.k.a. what immune system does, how the virus evolves, and what the virus does to the immune system) can be found on the Michael Palm Basic Science Blog, has just published an overview of vaccine and cure research in the TAG newsletter. The piece is a great introduction and update to a critical topic—and to learn more register for an upcoming AVAC webinar.
And for more on cure research, visit our CUREiculum page.
Thailand National Community Advisory Board
Amidst the 80-plus participants at AVAC’s African Partners’ Forum, one face may have stood out more than any other. The one participant from Thailand, an AVAC partner of almost eight years, brought into the room a global perspective and a wealth of research advocacy expertise— that, despite his solitary role and his sometimes quiet demeanor, was palpable throughout the three days.
Udom is a consultant for AVAC working on community engagement in HIV research, and a consultant for the Retrovirology Department of Armed Forces Research Institute of Medical Sciences (AFRIMS) on CAB constitution since 2010. His work at AVAC is to promote community participation in HIV research and Good Participatory Practice (GPP) implementation in the country. Udom is also a member of the National Subcommittee on HIV Vaccine Development and the National Subcommittee on Biomedical HIV Prevention representing the Thai civil society involving in HIV/AIDS. One of the founders of Thailand National Community Advisory Boards (NCAB) on HIV research.
Through the Thai NGO Coalition on AIDS, he has championed the AVAC/UNAIDS Good Participatory Practices—both with research entities and national bodies—and has helped move the dial on stakeholders’ roles in the research process in Thailand. We asked him to share his experiences with the group, in particular development of a National Community Advisory Board. Here are some of his words:
Community participation in HIV research in Thailand can be divided roughly into two stages – before RV144 stage, and RV144 (and beyond) stage. RV144 was the world’s largest HIV vaccine efficacy trial and conducted in Thailand. In Thailand, the concept of community participation in HIV research was rarely mentioned before the RV144 vaccine trial. In the pre-RV144 era, almost all HIV studies in Thailand were treatment, and participants were AIDS patients of the hospitals that also contain research centers. Hence there was no need to engage others besides the patients and their families. Recruitment strategies of that time were word of mouth, banners posted around the hospitals, and pamphlets. For HIV prevention trials such as HIV vaccine, recruitment might involve one or two meetings with villagers of the target area and the local health officers.
Due to its sheer size and the resources that came with it, RV144 inadvertently changed all of these. A few Thai AIDS activists heard about the trial for the first time at an international AIDS conference and were upset for being left out. They thus demanded that the researchers discuss the plan of the trial with the communities living in the target area to prepare them. Attempting to pacify the NGOs, the researchers held several meetings to discuss the ways to move forward with them. Even though both sides agreed that community participation was necessary, they couldn’t agree on the approach or the definition of community. At the same time, the model of the community advisory board (CAB) had been used in the USA for quite some time. The Thai NGOs involved in the meetings seized on the idea of CAB because it allows laypersons to become involved in HIV research, and it was romantically linked to AIDS activism. From then on, CAB became popular among Thai NGOs. Later on, some institutes conducting HIV research in the country also adopted the CAB model to appease Thai AIDS activists (or agitators depending on viewpoint) and to fulfill requirement of the trials’ sponsors. As a result, several CABs were desultorily formed; a couple of CABs were formed even before the responsible research institutes had a study to consult them with.
Unfortunately only the name (of CAB) is adopted. Most CABs in Thailand are not clear about their roles and responsibilities. In the beginning, a couple of CABs existed in name only. There was no meeting, no activity. The selection (of CAB members) process was, and still is, not clearly defined. Criterion for CAB members is ambiguous; some CABs include researchers and members of research teams as bona fide members. In many cases, CAB members were selected based on their deferential attitude toward researchers and staff rather than their qualifications, experiences, or representativeness. The only CAB activity is bimonthly meetings that dedicated mainly to routine update of the trials with very little (or no time) for other discussion. CAB members are not consulted about the meeting agenda ahead of the meeting. The consultations sought from CAB members in the meeting are limited to informed consent forms and, occasionally, educational/communication materials. Most CABs, except one, have never seen protocols of the studies about which they are to give advice. A few CAB members think that the purpose of informed consent is to absolve the researchers from legal responsibility. Many CAB members think that CAB is an additional arm of the research team to recruit people for the trials.
In general CAB members receive no formal or structured training on relevant topics including clinical research and research ethics. Other activities that could improve CAB capability are also lacking such as orientation for new members, mentoring and coaching for new and old members who may benefit from such activities, or reading materials to improve their research knowledge. Regarding capacity building for CAB, the only exception is the youngest CAB formed about 3 years ago by a bio-ethicist working with a few AIDS activists who have CAB experience. This particular CAB has regular CAB training sessions built into their bimonthly CAB meetings as well as annual training workshop and orientation for new members.
The idea of the national CAB was born during the implementation of RV144. A few AIDS activists involved in community engagement of the trial wanted to create an autonomous coordinating CAB to promote cross-learning between existing CABs. After informal discussions with other NGO workers who were CAB members of various research institutes and a meeting to discuss the idea, the national CAB was formed in May 2014. The goal of the National CAB is to promote ethical HIV clinical research through meaningful community participation. The national CAB wants to focus on capacity building in HIV research and research ethics for existing CABs and relevant community members. Members of the national CAB are selected from six HIV CABs in the country. Notwithstanding the name, the national CAB receives no funding from government agency or research institutes.
Almost from the beginning all associated research institutes, except one, are supportive of the national CAB. Only one research institute reckons that the national CAB has to be linked to specific institute/s and formalized by a government body.The national CAB meets every 2 months to discuss various topics that are not specific to trials or institutes but related to wider issues such as the national guidelines on HIV prevention and treatment, ethics of HIV research on vulnerable populations, and the drafts of the national law on human subjects research. The national CAB also conducts activities including GPP training for CABs and community groups, annual NCAB workshop, and training on research ethics for CABs and community groups.
It is too early to gauge the impact of the national CAB. For Thailand, this kind of CAB, an independent and NGO-initiated CAB, is unprecedented. Presently key HIV research institutes and a few HIV-related national bodies are aware of the national CAB and have no object regarding its existence or function. A chairperson of a national sub-committee related to HIV wants the national CAB to serve as additional IRB in parallel with other IRBs in reviewing biomedical HIV prevention trials conducted in Thailand. This is an important challenge for the national CAB considering its tender age and the members’ combined experience. To fulfill the expectation, members of the national CAB have to significantly improve their knowledge on HIV science and research ethics. They also have to expand their involvement horizontally and vertically. It is naïve to expect that this will be easy or encounter no opposition or resistance from other stakeholders. In the end it is left to members of the national CAB to prove that they are relevant and capable of the responsibility.