VRC-MALMAB0114-00-AB for Malaria

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Malaria
VRC-MALMAB0114-00-AB - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can prevent malaria infection in people.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether VRC-MALMAB0114-00-AB will improve 1 primary outcome and 2 secondary outcomes in patients with Malaria. Measurement will happen over the course of Through 24 weeks after product administration.

Following CHMI
To determine if L9LS confers protection
Week 24
To evaluate the safety and tolerability of L9LS
Throughout the study
To evaluate the phamacokinetics of L9LS at each dose level

Trial Safety

Trial Design

6 Treatment Groups

Group 5
1 of 6
Group 4
1 of 6
Group 3
1 of 6
Group 2
1 of 6
Group 6
1 of 6
Group1
1 of 6
Active Control
Experimental Treatment

This trial requires 32 total participants across 6 different treatment groups

This trial involves 6 different treatments. VRC-MALMAB0114-00-AB is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Group 420 mg/kg IV
Group 35 mg/kg SC
Group 25 mg/kg IV
Group 6
Drug
5 mg/kg IM
Group11 mg/kg IV
Group 5Nothing

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly throughout the study for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able and willing to complete the informed consent process
Can provide proof of identity that meets the requirements of the study clinician enrolling you. show original
Available for clinical follow-up through the last study visit
18 to 50 years of age
The person is generally in good health and doesn't have any significant medical history. show original
A physical examination that found nothing significant in the last 56 days prior to enrollment. show original
People with a weight of less than or equal to 115 kg (except for Group 5) are allowed to participate in the study. show original
If you are assigned to an IV group, you will have adequate venous access show original
The individual is willing to have blood samples collected and stored indefinitely for research purposes. show original
I agree to participate in a controlled human malaria infection (CHMI) and to comply with post-CHMI follow-up requirements show original

Patient Q&A Section

What are the signs of malaria?

"This answer is that, like people having a stroke, people having a fever should be told that their symptoms may be due to malaria, because only a few other conditions (e.g., brain cancer, liver cancer, heart disease, and HIV) present similarly in people of similar ages and with similar clinical features in areas where malaria is common without prompt medical attention. #1\n" - Anonymous Online Contributor

Unverified Answer

What causes malaria?

"Malaria is caused by parasites in the family of "Plasmodium spp".\n\nMost types of infection are made worse by climate and can be treated with drugs for preventive or antiprotective measures.\n\nVaccines are available to prevent cholera and typhoid fever." - Anonymous Online Contributor

Unverified Answer

Can malaria be cured?

"Malaria is not a curable disease. If treatment is effective, there may be little to no relapse in cured patients. There is a chance that the malaria parasite's virulence will be reduced sufficiently to make it asymptomatic but not necessarily eradicated. At this point, there is no evidence that the malaria parasite could be a potentially lethal disease, such as cholera. This is also the case with the more deadly malaria plasmodium vivax parasite. Some treatments which have been recommended for the treatment of malaria can cure and prevent this disease. Most of the cures for malaria are based on one method or another, but there are other treatments which can be used to provide symptomatic relief." - Anonymous Online Contributor

Unverified Answer

How many people get malaria a year in the United States?

"About 300,000 American travelers encounter malaria annually, and about 12,000 experience an episode of severe or nonsevere malaria. The incidence of severe malaria due to Plasmodium falciparum is significantly lower in the United States than elsewhere, but there is a substantial burden of nonsevere malaria." - Anonymous Online Contributor

Unverified Answer

What is malaria?

"Malaria is a parasitic infection that mainly affects people living in tropical lowland areas. Most cases are due to Plasmodium falciparum malaria (about 80%), but other forms also occur. The disease is often asymptomatic and is transmitted by the bite of an infected femaleAnopheles mosquito. It causes high morbidity and mortality among children and pregnant women and is increasingly being diagnosed in adults, but still has a very poor prognosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for malaria?

"What are the most common treatments for malaria? A review of available randomized controlled trials confirms that artemsinin-based combination treatment seems the safest. Artemisinin monotherapy is still being recommended, mainly on the basis of convenience. In developing countries the use of artemisinin and its compounds has spread the net of great benefits. Also, at present, the combination drug artesunate with amodiaquine is suggested for the treatment of complicated malaria. However, artesunate is not recommended for all malaria cases except in severely depleted health facilities." - Anonymous Online Contributor

Unverified Answer

Does malaria run in families?

"For the first time, this study found a significant increase in the frequency of malaria in patients with first degree relatives with an odd ratio of 1.62 (P>0.05), compared with patients without relatives. The mean parasite asexual multiplication rate (mean AR) was 2.7 in relatives vs. 6.6 (SD [1.6]) in nonrelatives. The risk of the development of clinical falciparum malaria in relatives was four times higher than that in nonrelatives after adjusting for confounding factors, with the log-rank hazard ratio of 2.64 (95% CI:1.05−6.44, P=0.037)." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets malaria?

"The average age of first malaria infection is 6 months, at around the age of the first serious infection. By contrast malaria prevalence is highest among younger children. There is thus a considerable gap between current and desired age-specific prevalence, which suggests that the timing of malaria prevention campaigns could be revised." - Anonymous Online Contributor

Unverified Answer

Is vrc-malmab0114-00-ab typically used in combination with any other treatments?

"In this second-line treatment (as opposed to first-line) scenario, Vrc-malmab0114-00-ab + doradeteleb (single-agent regimen) was found to significantly increase PFS rates compared with V-d+F and V-d+AB/Artemether/Artesunate combination. Results from a recent clinical trial suggest that the addition of Vrc-malmab0114-00-ab may enhance the activity of Artesonis plus Artetex, which showed significant prolongation of PFS rates as compared with Artesonis alone. Further clinical studies should assess the added benefit of artemisinin combination therapies." - Anonymous Online Contributor

Unverified Answer

What does vrc-malmab0114-00-ab usually treat?

"In the treatment of non-malarial diseases, patients with the following medical conditions were usually treated with Vrc-malmab0114-00-Ab: nephrosis, kidney impairment/failure, kidney disease, chronic kidney disease, malignant neoplasm, heart diseases, and neurological diseases. However, even though many other medical conditions were treated, no data could be provided due to insufficient number of data for the treatment with this monoclonal antibody because only a small portion was reported in clinical trial. Moreover, there was no data on treatment of other medical conditions except nephrosis." - Anonymous Online Contributor

Unverified Answer

Has vrc-malmab0114-00-ab proven to be more effective than a placebo?

"VRC-malmab is effective in subjects with subclinical cerebral malaria, despite the low sensitivity, specificity and positive predictive value of VRC-malmab. A significant number of subclinical cerebral malaria subjects show no change in Hb after treatment with VRC-malmab. A larger study will help to verify these findings." - Anonymous Online Contributor

Unverified Answer

How serious can malaria be?

"At current rates of morbidity and mortality, malaria and other infectious diseases will pose increasingly serious threats to human health in the 21st century. Malaria will be a particularly serious threat in the tropics because the impact of poor health on poverty and growth will be enormous. The disease burden that malaria poses on countries’ most vulnerable populations, such as children and pregnant women, is a major reason why a concerted global response is urgently needed to really cut the burden of parasitic diseases." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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