Investment by Technology

Preventive HIV vaccines

1.0 Global investment in preventive HIV vaccines R&D

In 2019, funding for preventive HIV vaccine R&D increased by a marginal 0.7 percent or US$6 million from the previous year, and totaled US$848 million. The public sector accounted for 81 percent of overall investment, at US$686 million, with the philanthropic and commercial sectors contributing 13 percent and six percent, respectively. At US$662 million or 78 percent of all public sector funding, the US remained the largest donor of preventive vaccine research globally. US public sector funding increased by six percent from 2018 levels, an uptick bolstered by the six percent increase in funding from the National Institutes of Health (NIH) that brought its contribution to US$597 million.

European investment in preventive vaccine R&D decreased by 22 percent and amounted to US$18 million, the lowest levels observed since 2000. Philanthropic contributions decreased by 15 percent and totaled US$111 million. This trend is mostly attributed to the US$19 million decrease in funding from the Bill and Melinda Gates Foundation (BMGF), which funded preventive vaccine research at US$99 million in 2019. 

The commercial sector contributed US$50.7 million although this number is likely a result of under-reporting from the sector. 

The Netherlands, Denmark and Canada increased their commitments in 2019, which helped cushion against decreases from France, UK, Italy, Switzerland and Germany. Funding from the European Commission also decreased from US$9.5 million to US$9.3 million in 2019.

0 %
increase in HIV vaccine R&D in 2019

1.1 Developments in the field of preventive HIV vaccine research 

The diverse pipeline for HIV vaccine candidates continues to advance, with multiple large-scale trials underway. This is the busiest the pipeline has ever been with dozens of innovative new approaches under investigation. 
  • “Mosaic-based” vaccines designed to protect against a wide variety of HIV subtypes are being tested in two efficacy trials: Imbokodo  (HPX2008/HVTN 705), a trial in five countries in sub-Saharan Africa1, and the Mosaico trial (HPX3002/HVTN 706) in eight countries across the Americas and Europe2.
  • The innovative PrEPVacc study began enrollment in December 2020 and will be conducted in four African countries, testing two vaccine regimens and comparing two daily oral pre-exposure prophylaxis (PrEP) options, F/TDF (Truvada) and F/TAF (Descovy)3.
The field did experience a significant disappointment in 2020 with an early stop to vaccinations in the HVTN 702 vaccine study after a futility finding. However, what is learned from HVTN 702 can help make future HIV vaccine research efforts smarter4.

1.2 Funding allocations for preventive HIV vaccine R&D

Funding for HIV vaccine R&D was allocated to the following areas in 2019: basic research (17.3 percent), preclinical (46.5 percent), clinical (34.4 percent), cohort and site development (1.3 percent) and advocacy and policy (0.5 percent). As observed since 2016, preclinical research out-funded clinical trials. Further information about the categories used to define R&D can be found in the Methodology section of the Appendix.a

Interested in learning about HIV vaccines?

Track the research pipeline and more with AVAC.

Microbicides

2.0 Global investment in microbicide R&D

Investment in microbicide R&D totaled US$154 million in 2019, a six percent (US$9 million) decrease from 2018 funding levels. Not only is this the seventh consecutive year of declining microbicide funding, but it also represents the lowest level recorded since 2005. The public sector remained the largest donor at 98 percent of funding, with the remaining two percent originating from philanthropy. Public funding decreased by six percent and fell to US$151 million, while philanthropic funding increased by 95 percent from the previous year to US$3.5 million. Even though philanthropic funding increased nearly 100 percent due to increased commitments from BMGF, it was not enough to make up for the US$10 million decrease in public sector funding.

6 %
decrease in microbicide R&D in 2019

The US remained the largest funder of microbicide research at US$134 million, with USAID contributing US$45 million and the NIH US$87.8 million. European funding shrunk by 33 percent to US$16.9 million. Zero allocations for microbicide R&D from the German Federal Ministry of Education and Research (BMBF) and the Netherlands Ministry of Foreign Affairs explain the drop in European funding. In 2018, these funders collectively contributed US$9 million. The two philanthropies backing microbicide R&D saw an increase in funding from 2018 levels, with BMGF rising to US$3.2 million and Institut Pasteur to US$0.3 million.

 
 

2.1 Developments in the field of microbicide research

A diverse range of microbicide strategies are under investigation and some products are closer than ever to being rolled out as discreet and female-initiated HIV prevention options. 
  • The first microbicide to be submitted for regulatory approval, the Dapivirine Vaginal Ring (DPV-VR), was recommended by the World Health Organization (WHO) as an additional prevention choice for women at substantial risk of HIV infection5. The ring, which is designed as a 28-day long-acting product, had previously received a positive opinion from the European Medicines Agency in July 2020 and was added to the list of WHO’s prequalified medicines in November 2020. 
A 90-day vaginal ring designed as a dual-purpose product conferring both contraceptive and HIV protection was found to be effective in early-phase testing. Results of the study, MTN-044/IPM 053/CCN019, were presented at the HIV Research for Prevention (HIVR4P) Virtual Conference6.

2.2 Funding allocations for microbicide R&D

Allocations for microbicide R&D in 2019 were as follows: basic mechanisms of mucosal transmission (six percent), preclinical research (13   percent), formulations and modes of delivery (12 percent), clinical trials (40 percent), behavioral and social science research (11 percent), research infrastructure (12 percent) and advocacy and policy (six percent).

Interested in learning about the dapivirine vaginal ring and other microbicides?

Track the research pipeline and more with AVAC.

Pre-Exposure Prophylaxis (PrEP)

3.0 Global investment in PrEP R&D

In 2019, global investment in PrEP R&D totaled US$99 million; a 16 percent increase from levels observed in 2018. Investment from the philanthropic sector increased by 56 percent, rising to US$33.8 million. This trend is linked to the rise in BMGF funding, from US$21 million to US$33 million. US public sector donors also recorded increased funding, with NIH funding up 15 percent to US$42 million and CDC funding up to US$1.4 million. Commercial sector investment in PrEP remained mostly unchanged at US$19 million.

 
 
0 %
increase in PrEP R&D in 2019

3.1 Developments in the field of PrEP research

Uptake of oral PrEP grew substantially in 2020: there were over 300,000 new initiations globally, bringing the total cumulative initiations since PrEP was introduced to 928,750. Sub-Saharan Africa comprised 56% of global uptake. Yet scale-up remains concentrated, with only 11 countries counting more than 25,000 initiations by the end of 2020. Strengthening oral PrEP implementation will lay a solid foundation for introduction of next-generation products. Recent results from trials of a long-acting injectable and once-monthly pill indicate that a diverse array of biomedical prevention products is on the horizon.
  • Early results from HPTN 083 and HPTN 084, two Phase III studies of a long-acting injection of the antiretroviral cabotegravir (CAB-LA)77 were released in 2020. HTPN 083 is a randomized, controlled, double-blind study that enrolled 4,570 cisgender men and transgender women who have sex with men in the Americas, Asia, and South Africa. HPTN 08388 found that CAB-LA demonstrated safety and high efficacy for reducing HIV risk among gay men and other men who have sex with men and transgender women. HPTN 084 is a randomized, controlled, double-blind study that enrolled 3,223 cisgender women in sub-Saharan Africa. HPTN 08499 found CAB-LA to be comparatively more effective than oral PrEP in cisgender women – reducing HIV risk by 89 percent more compared to oral PrEP. Both options reduced risk and were found to be safe.
Promising interim findings from Phase IIa trials of the once-monthly pill of antiretroviral Islatravir were released in January 202110. The results found Islatravir to be safe, well-tolerated in the blood over time, and it reached levels adequate for HIV prevention for a duration of at least one month1111. Islatravir will move into efficacy trials in 2021.

See how the uptake of oral PrEP has expanded globally since 2014 with PrEPWatch, and learn more about the next-generation of PrEP products.

Other biomedical prevention options

4.0 Global investment in treatment as prevention (TasP) R&D

Investment in TasP R&D continued to decline in 2019, decreasing 19 percent to US$1.7 million. A marginal increase in philanthropic funding was neutralized by a 24 percent decrease in the public sector. However, recent decreases in TasP funding are linked to the completion of the CDC-funded Botswana Combination Prevention project, which had been ongoing since 2013. Multiple large-scale trials such as HPTN 052, PARTNER, Opposites Attract, PARTNER 220 and HPTN 071 have demonstrated the effectiveness of treatment to reduce onward transmission. This established and robust evidence base likely explains the sharp decline in R&D investment for TasP since 2015.

19 %
decrease in TasP R&D in 2019

Interested in learning about treatment as prevention? See this resource from the US CDC 

5.0 Global investment in the female condom

The Female Health Company remained the only funder for female condom research and contributed US$0.06 million. This was a 49 percent increase from 2018.

0 %
increase in female condom research in 2019

Interested in learning about male and female condoms? Track the research and find out more with AVAC.

6.0 Global investment in voluntary medical male circumcision (VMMC)

Investment in VMMC research decreased by three percent and totaled US$9 million. BMGF was the largest donor at US$7.6 million, followed by the NIH at US$1.3 million. Sufficient empirical studies have already affirmed the efficacy of VMMC as a prevention option, which is likely why over 50 percent of the research is allocated to implementation science and the large-scale rollout of services. Other areas of focus include behavioral and social science research (25 percent) and advocacy and policy development (25 percent).

17 %
decrease in VMMC R&D in 2019

Interested in learning about the benefits of voluntary medical male circumcision? Track the research and rollout with AVAC.

7.0 Global investment in Prevention of vertical transmission

Funding for PMTCT decreased by four percent, with levels shrinking from US$36 million to US$34.6 million. The number of donors financing PMTCT research decreased from twelve to eight, with BMGF being the only philanthropic donor. Most PMTCT research (almost 96 percent) was funded by the public sector, with the US NIH remaining the largest donor at US$29 million.  European funding decreased by 12 percent, falling to US$2.9 million. Philanthropic funding levels also rose to US$1.5 million, bolstered by increased support from BMGF.p

4 %
decrease in Prevention of Vertical Transmission R&D in 2019

Interested in learning about prevention of vertical transmission? See this resource from the Avert.

Footnotes

  1. A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa – Full Text View – ClinicalTrials.gov. Clinicaltrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT03060629.
  2. A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals – Full Text View – ClinicalTrials.gov. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT03964415.
  3. A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP – Full Text View – ClinicalTrials.gov. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066881. Published 2020.
  4. HVTN 702 Stopped Early for Non-Efficacy. AVAC. https://www.avac.org/blog/hvtn-702-stopped-early-non-efficacy. Published 2020.
  5. WHO recommends the dapivirine vaginal ring as a new choice for HIV prevention for women at substantial risk of HIV infection. Who.int. https://www.who.int/news/item/26-01-2021-who-recommends-the-dapivirine-vaginal-ring-as-a-new-choice-for-hiv-prevention-for-women-at-substantial-risk-of-hiv-infection. Published 2021.
  6. Microbicide Trials Network. Second Early Phase Study Of 90-Day Vaginal Ring Containing Dapivirine And Contraceptive Shows Promise As Dual-Purpose Product For Preventing Both HIV And Pregnancy.; 2021.
  7. Long Acting Injectables – PrEPWatch. PrEPWatch. https://www.prepwatch.org/nextgen-prep/long-acting-injectables/.
  8. HIV Prevention Trials Network. HPTN 083 Study Demonstrates Superiority Of Cabotegravir For The Prevention Of HIV.; 2020. https://www.hptn.org/news-and-events/press-releases/hptn-083-study-demonstrates-superiority-cabotegravir-prevention-hiv.
  9. HIV Prevention Trials Network. HPTN 084 Study Demonstrates Superiority Of CAB LA To Oral FTC/TDF For The Prevention Of HIV.; 2020. https://www.hptn.org/news-and-events/press-releases/hptn-084-study-demonstrates-superiority-of-cab-la-to-oral-ftctdf-for.
  10. Data from Antibody-Mediated Prevention Studies Advance the Field and Show the Challenges that Lie Ahead. AVAC. https://www.avac.org/press-release/antibody-mediated-prevention-studies-advance-field. Published 2021.
  11. Highleyman L. Islatravir Shows Promise for Once-Monthly Oral PrEP. POZ. https://www.poz.com/article/islatravir-shows-promise-oncemonthly-oral-prep. Published 2021. Accessed February 3, 2021.