Phase 1 Human Immunodeficiency Virus (HIV) Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Subtype C DNA and MF59-Adjuvanted Subtype C Envelope Protein.

BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. METHODS: In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1-uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. RESULTS: All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P = .02), but not in the coadministration regimen (43.3% vs 48.3%; P = .61). CONCLUSIONS: Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).

Removal of an embedded crochet needle in the mouth.

A 3-year-old child presented to the emergency department with a crochet needle lodged in her posterior oral cavity. To localize the needle and significant surrounding anatomic structures, bedside transcavitary ultrasound was employed. After careful localization, the needle was removed using a modified needle cover technique. A review of barbed foreign object removal techniques, including advance-and-cut, retrograde, string-yank, and needle cover techniques, is presented. Important considerations while planning any procedure include risk, benefit, availability of staff, and availability of equipment. Proper anesthesia is paramount to the success of these procedures, and sedation in pediatric patients may prove necessary. Postprocedure wound care and follow-up must also be arranged. This case demonstrates the importance of adaptation of well-documented techniques to remain flexible for any situation that may present to the emergency department.

The effect of multiple uses of disposable diamond burs on restoration leakage.

BACKGROUND: The authors tested the clinical longevity of disposable diamond burs. They cut a series of five preparations and assessed the leakage after restoring the tooth. METHODS: The authors prepared 10 teeth for Class V restorations, and used a new disposable diamond bur for each tooth. The burs were used to cut preparations in extra teeth before being used to prepare a second series of 10 teeth (third use). The authors then cut preparations in extra teeth before preparing a third set of 10 teeth (fifth use). They removed existing restorations in a second group of 30 teeth and extended the preparations using the same regimen of one, three and five bur uses. All preparations were etched and conditioned, and the teeth were restored with resin-based composite. Using a 20-volt direct-current power source and a stainless-steel counter electrode, the authors measured the leakage electrochemically in 1.0 percent sodium chloride for 30 days. RESULTS: Freshly prepared and restored teeth leaked less than reprepared teeth. Leakage was similar for the first and third uses of the bur, but was far greater for the fifth use (P < .01). The previously restored teeth that were cut with the first- and third-use burs behaved the same, but the third-use bur caused more leakage than the fifth-use bur (P < .01). CONCLUSIONS: Reuse of disposable burs can affect leakage behavior. With new preparations, use of a disposable bur to cut more than three preparations increased leakage. For teeth that were reprepared and restored, greater leakage occurred than it did with new preparations, although repeated use of a bur may reduce leakage. CLINICAL IMPLICATIONS: Disposable diamond burs may cut preparations in up to three teeth before adversely affecting leakage behavior. Restoration removal and repreparation of teeth results in greater leakage than that with freshly prepared teeth.