Monoclonal antibody shows promise against dengue viremia, fever in phase 2 trial

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Dengue
Close-up of an Aedes aegypti mosquito
Monica R / Flickr cc

An experimental monoclonal antibody (mAb) for dengue virus was safe and well-tolerated and provided evidence of a therapeutic effect in a phase 2 clinical trial, researchers reported last week in JAMA Network Open.

In the randomized, placebo-controlled trial, a team led by investigators from Serum Institute of India assigned 250 adults with dengue and a history of fever onset within 48 hours to receive four different dose levels of Dengue-mAb (3, 5, 7, or 9 milligrams per kilogram [mg/kg]) or a placebo, with 50 participants assigned to each group. The primary outcomes were reduction in viremia at 24 hours and causally related serious adverse events (SAEs).

Dengue-mAb is a human-engineered, recombinant monoclonal antibody that has neutralized all four serotypes of dengue virus in animal studies and demonstrated safety in a phase 1 trial in healthy adults.

Dengue virus affects more than 200 million people each year and is expanding into new areas amid climate change and rapid urbanization. In addition, the incidence of severe disease from the fast-spreading mosquito-borne virus is rising. While there are three currently licensed vaccines for dengue, there are no licensed antiviral drugs. 

“Improvements in case management to reduce the risk of severe dengue are still needed,” the investigators wrote.

Rapid clearance of viremia, fever

Treatment with Dengue-mAb demonstrated a rapid clearance of dengue viremia and fever within 24 hours at all dose levels compared with placebo. Participants with detectable viremia at baseline were negative for dengue virus by eight hours when treated with the 5- to 9-mg/kg dose of Dengue-mAb, compared with 72 hours with placebo. 

At 24 hours, fever clearance ranged from 92.9% to 100% in the Dengue-mAb groups, compared with 58.3% in the placebo group.

This is, to our knowledge, the first evidence of a preliminary therapeutic effect in patients with dengue.

No causally related SAEs were recorded.

“This first-in-patient phase 2 randomized clinical trial demonstrated the safety of Dengue-mAb and its action on the clearance of dengue virus and fever,” the authors wrote. “This is, to our knowledge, the first evidence of a preliminary therapeutic effect in patients with dengue.”

HPV infection may confer slightly higher risk of new-onset heart disease and death

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Human Papillomavirus (HPV)
Clinician about to listen to woman's heart
Chinnapong / iStock

Women infected with human papillomavirus (HPV) are at higher risk for new-onset cardiovascular disease (CVD) and death than their uninfected peers, a Karolinska Institutet–led research team suggests.

For the observational study, published yesterday in PLOS Medicine, the researchers compared the CVD diagnoses of 497,445 HPV-infected women in Swedish national registries with those of roughly 2.5 million uninfected controls. They also compared CVD status among 143,787 infected women and their 174,637 unexposed full siblings.

The authors note that most previous observational research was limited to specific populations and didn’t adequately consider familial factors. HPV infection is well known to cause cervical cancer, but emerging evidence suggests that it may also contribute to CVD.

Sibling comparison yields similar findings

New-onset CVD was identified in 28,793 and 128,373 HPV-infected and uninfected women, respectively, for respective incidences of 8.27 and 7.93 per 1,000 person-years. In total, 1,221 and 4,941 women with and without HPV infection died of CVD, for respective death rates of 33.7 and 29.4 per 100,000 person-years. The risks of CVD and death were greatest within the first year of follow-up, then waned.

The findings suggested that clinicians should be aware of a slightly elevated CVD risk in women with HPV, especially during the first year following an infection.

The risk of new-onset CVD was 7% higher in HPV-infected women than in their uninfected counterparts, for an absolute rate difference of 0.53 cases per 1,000 person-years (population-attributable fraction, 1.16%). 

The risk of death was 25% higher in infected women than in unexposed women, for an absolute rate difference of 6.71 cases per 100,000 person-years (population-attributable fraction, 4.12%).

In the first year of follow-up, the risks of incident CVD and related death were 43% and 86% higher, respectively, in women diagnosed as having HPV. But thereafter, the excess risk fell to 2% for new-onset CVD and 21% for related death.

In the sibling comparison, HPV-infected women had a 5% greater risk of incident CVD and a 25% higher risk of death than their uninfected siblings.

“The findings suggested that clinicians should be aware of a slightly elevated CVD risk in women with HPV, especially during the first year following an infection,” the authors concluded. “However, given the small absolute difference, women should not be unduly concerned.”

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